RU2829795C1 - Drug delivery system configured to define drug dosing schedule - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to a drug delivery system using a drug delivery and/or drug delivery device. Drug delivery system comprises a drug delivery device and at least one sensor. Drug administration device comprises a communication interface configured to communicate with a communication interface of a computer system. At least one sensor is configured to receive sensor data and transmit sensor data to the drug delivery device. Drug administration device is configured to: using a first drug dosing regimen when a drug is delivered from a drug delivery device to a patient; determining a second drug dosing schedule for drug delivery from a drug delivery device to a patient. Second dosage regimen of the drug depends on the following: dispensing data from the computer system and sensor data from the at least one sensor obtained by the at least one sensor during and/or after drug delivery in accordance with the first drug dispensing schedule; and using a second drug delivery schedule when the drug is delivered from the drug delivery device to a patient. According to a second embodiment, a drug delivery system comprises at least one user interface configured to receive data entered by a user, and transmitting data entered by the user to the drug delivery device. Second drug dosing schedule also depends on data entered by the user from at least one user interface and obtained by the user interface during and/or after drug delivery from the drug delivery device in accordance with the first drug dosing schedule.

EFFECT: disclosed is a drug administration system configured to determine a drug dosing schedule.

18 cl, 16 dwg

Description

FIELD OF INVENTION

[0001] The embodiments described herein relate to a device for administering and/or delivering a drug. The present invention further relates to a system in which the device can be used, and to a method of administration and an additional method associated with the system.

PREREQUISITES FOR THE CREATION OF THE INVENTION

[0002] Pharmaceutical products (including large and small molecule pharmaceuticals, hereinafter "medicines") are administered to patients by various routes for treatment of specific medical indications. Regardless of the route of administration, care must be taken when administering medicinal products to avoid adverse events in the patient. For example, care must be taken not to administer more than a safe amount of a medicinal product to the patient. This requires consideration of the amount of dose to be administered and the time frame over which the dose is delivered, sometimes in relation to previous doses or doses of other medicinal products. In addition, care must be taken not to inadvertently administer to the patient an inappropriate or spoiled medicinal product due to expiration or improper storage. All of these considerations may be reflected in the instructions for use of specific medicinal products or their combinations. However, these instructions are not always followed correctly, for example, due to errors such as human error. This may result in adverse effects for the patient or in incorrect administration of the drug, such as too little or too much of the drug being administered for a specific medical indication.

[0003] Medications are typically administered to patients according to a medication dosing schedule. Medication dosing schedules may specify the volume of medication to be administered, the frequency of medication administration, the time of medication administration, etc. Typically, a physician or other healthcare professional will establish an initial medication dosing schedule for a patient based on dosing data such as the patient's weight, height, and age. However, this initial medication dosing schedule may not be optimal and will also not take into account factors that influence a patient's response to the medication dosing schedule, but which also change over time. Thus, a patient may need to monitor both his or her response to the medication dosing schedule and factors that may influence the response in order to actively cooperate with physicians to optimize the medication dosing schedule and ensure its effectiveness.

[0004] Optimization of drug dosing regimens relies heavily on patient compliance with the initial drug dosing regimen and accurate regular monitoring of the patient's symptoms. In addition, in some cases, the patient may need to monitor a large number of factors and take all of these factors into account when calculating the adjustment of the dosing regimen. If the patient fails to adequately account for all of the necessary factors or adequately control their symptoms, the drug dosing regimen may not be adjusted accordingly and may therefore be ineffective.

[0005] Depending on how the drug is administered to the patient, various dosage forms may be used. For example, these dosage forms may include parenteral, inhalation, oral, ophthalmic, nasal, topical, and suppository forms of one or more drugs.

[0006] Dosage forms may be administered directly to a patient via a drug administration device. There are a number of different types of drug administration devices generally available for delivering different dosage forms, including: syringes, injection devices (e.g., auto-injectors, jet injectors, and infusion pumps), nasal spray devices, and inhalers.

SUMMARY OF THE INVENTION

[0007] In one aspect, a drug administration system is provided, which in one embodiment includes a drug administration device that includes a communication interface configured to exchange data with a communication interface of a computer system. The drug administration device also includes at least one sensor configured to receive sensor data and to transmit the sensor data to the drug administration device. The drug administration device is configured to use a first drug dosing schedule when delivering the drug from the drug administration device to the patient and to determine a second drug dosing schedule for delivering the drug from the drug administration device to the patient. The second drug dosing schedule depends on the dosing data of the computer system and the sensor data received from the at least one sensor. The sensor data is received by the at least one sensor during and/or after the drug delivery in accordance with the first drug dosing schedule. The drug administration device is also configured to use the second drug dosing schedule when delivering the drug from the drug administration device to the patient.

[0008] The drug administration device may vary in any number of ways. For example, the drug administration device may be configured to determine a first drug dosing schedule for delivering the drug to the patient prior to using the first drug dosing schedule when the drug is delivered from the drug administration device to the patient. In another example, each of the first and second drug dosing schedules may indicate one or more of the following drug dosing parameters: a drug delivery rate, a drug delivery time and/or date, a drug volume, and a drug delivery duration. In another example, at least one sensor may include one or more of a patient monitoring sensor configured to receive sensor data related to a patient's condition, a device sensor configured to receive sensor data related to a drug administration device, an environmental sensor configured to receive sensor data related to an environment in which the drug administration device is present, and a location sensor configured to receive sensor data related to a geographic location of the drug administration device. In yet another example, the drug administration system may also include at least one external sensor configured to receive external sensor data and transmit external sensor data to a computer system, and the second drug dosing scheme may further depend on external sensor data from the computer system. In another example, the drug administration system may also include a second drug administration device that includes a communication interface configured to exchange data with a communication interface of a computer system, wherein the drug administration may also include at least one sensor configured to receive additional sensor data and transmit the additional sensor data to the second drug administration device, and the second drug dosing schedule may be further defined as dependent on the additional sensor data from the computer system.

[0009] In another example, the drug administration system may also include a second drug administration device that includes a communication interface configured to exchange data with a communication interface of a computer system, wherein the drug administration may also include at least one user interface configured to receive additional user input data and transmit the additional user input data to the second drug administration device, and the second drug dosing schedule may be further defined as dependent on the additional user input data from the computer system. In at least some embodiments, the system may also include at least one sensor configured to receive additional sensor data and transmit the additional sensor data to the second drug administration device, and the second drug dosing schedule may be further defined as dependent on additional sensor data from the computer system. At least one sensor can be configured to obtain additional sensor data that includes one or more of the following: a patient monitoring sensor configured to obtain additional sensor data related to the patient's condition, a device sensor configured to obtain additional sensor data related to the second device for administering a drug, an environmental sensor configured to obtain additional sensor data related to the environment in which the second device for administering a drug is present, and a location sensor configured to obtain additional sensor data related to the geographic location of the second device for administering a drug.

[0010] In another example, the drug administration device may be an autoinjector, and each of the first and second dose drug administration patterns may indicate one or more of the following parameters: a depth of advancement of the outlet port during drug delivery to the patient, a velocity of the outlet port during drug delivery to the patient, and an acceleration of the outlet port during drug delivery to the patient. In yet another example, the drug administration device may be an inhaler. In another example, the drug administration device may be an infusion pump.

[0011] In another example, the first drug dosing schedule may be determined to be dependent on dosing data transmitted from the computer system. In yet another example, each of the first and second drug dosing schedules may indicate one or more of the following: a drug delivery rate, a drug volume, and a drug delivery duration, and the value of one or more parameters in the first drug dosing schedule differs from the value of the corresponding parameter in the second drug dosing schedule.

[0012] In another example, the medicament may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0013] In another embodiment, a drug administration system comprises a drug administration device that includes a communication interface configured to exchange data with a communication interface of a computer system. The system also includes at least one user interface configured to receive user data and transmit user input data to the drug administration device, wherein the drug administration device is configured to use a first drug dosing schedule when the drug is delivered from the drug administration device to a patient, and determines a second drug dosing schedule for delivering the drug to the patient. The second drug dosing schedule depends on dosing data from the computer system and user input data from at least one user interface. The user input data is received via the user interface during and/or after the drug is delivered from the drug administration device in accordance with the first drug dosing schedule. The drug administration device is also configured to use the second drug dosing schedule when delivering the drug from the drug administration device to the patient.

[0014] The drug administration system may have any number of variations. For example, the drug administration device may be configured to determine a first drug dosing schedule for delivering the drug from the drug administration device to the patient before using the first drug dosing schedule when the drug is delivered from the drug administration device to the patient. In another example, the system may include at least one sensor configured to receive sensor data and transmit the sensor data to the drug administration device, wherein the drug administration device may be configured to determine a second drug dosing schedule, with further dependence on the sensor data of the at least one sensor, and the sensor data may be received by the at least one sensor during and/or after delivering the drug from the drug administration device in accordance with the first drug dosing schedule. In another example, each of the first and second drug dosing regimens may indicate one or more of the following drug dosing parameters: drug delivery rate, drug delivery time and/or date, drug volume, and drug delivery duration.

[0015] In another example, at least one sensor may include one or more of a patient monitoring sensor configured to obtain sensor data related to a patient's condition, a device sensor configured to obtain sensor data related to a drug administration device, an environmental sensor configured to obtain sensor data related to an environment in which the drug administration device is present, and a location sensor configured to obtain sensor data related to a geographic location of the drug administration device.

[0016] In another example, the drug administration system may also include at least one external sensor configured to receive external sensor data and transmit external sensor data to the computer system, and the second drug dosing scheme may further depend on external sensor data from the computer system.

[0017] In another example, the drug administration system may also include a second drug administration device that includes a communication interface configured to exchange data with a communication interface of the computer system, wherein the drug administration may also include at least one sensor configured to receive additional sensor data and transmit the additional sensor data to the second drug administration device, and the second drug dosing regimen may be further defined as dependent on the additional sensor data from the computer system.

[0018] In another example, the drug administration system may also include a second drug administration device that includes a communication interface configured to exchange data with a communication interface of a computer system, wherein the drug administration may also include at least one user interface configured to receive additional user input data and transmit the additional user input data to the second drug administration device, and the second drug dosing schedule may be further defined as dependent on the additional user input data from the computer system. In at least some embodiments, the system may also include at least one sensor configured to receive additional sensor data and transmit the additional sensor data to the second drug administration device, and the second drug dosing schedule may be further defined as dependent on additional sensor data from the computer system. At least one sensor can be configured to obtain additional sensor data that includes one or more of the following: a patient monitoring sensor configured to obtain additional sensor data related to the patient's condition, a device sensor configured to obtain additional sensor data related to the second device for administering a drug, an environmental sensor configured to obtain additional sensor data related to the environment in which the second device for administering a drug is present, and a location sensor configured to obtain additional sensor data related to the geographic location of the second device for administering a drug.

[0019] In another example, the drug administration device may be an autoinjector, and each of the first and second dose drug administration patterns may indicate one or more of the following parameters: a depth of advancement of the outlet port during drug delivery to the patient, a velocity of the outlet port during drug delivery to the patient, and an acceleration of the outlet port during drug delivery to the patient. In another example, the drug administration device may be an inhaler. In another example, the drug administration device may be an infusion pump.

[0020] In another example, the first drug dosing schedule may be determined to be dependent on dosing data transmitted from the computer system. In yet another example, each of the first and second drug dosing schedules may indicate one or more of the following: a drug delivery rate, a drug volume, and a drug delivery duration, and the value of one or more parameters in the first drug dosing schedule differs from the value of the corresponding parameter in the second drug dosing schedule.

[0021] In another example, the medicament may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0022] In another aspect, a method is provided for determining a drug dosing regimen for delivering a drug to a patient, and in one embodiment includes delivering a drug to the patient in accordance with a first drug dosing regimen using a drug administration device; receiving sensor data using the sensor; determining on the drug administration device a second drug dosing regimen for delivering a drug from the drug administration device to the patient depending on the sensor data and dosing data from a computer system; and delivering the drug to the patient in accordance with the second drug dosing regimen using the drug administration device.

[0023] The method may have any number of variations. For example, the method may also include determining on the drug administration device a first drug dosing schedule for delivering drugA to the patient before delivering the drug to the patient in accordance with the first drug dosing schedule.

[0024] In another example, each of the first and second drug dosing regimens may indicate at least one of a drug administration rate, a drug volume, and a drug delivery duration. In another example, obtaining sensor data using a sensor includes at least one of the following: obtaining sensor data related to a patient condition using a patient monitoring sensor, obtaining sensor data related to a drug administration device using a device sensor, obtaining sensor data related to an environment in which the drug administration device is present using an environmental sensor, and obtaining sensor data related to a geographic location of the drug administration device using a location sensor. In another example, the method may include obtaining external sensor data using an external sensor, and determining a second drug dosing regimen for delivering the drug to the patient may include determining a second drug dosing regimen, with further dependence on the external sensor data. In another example, the method may include obtaining additional sensor data using an additional sensor, wherein the method may include transmitting the additional sensor data to a second drug delivery device, and determining a second drug dosing schedule for delivering the drug to the patient may include determining a second drug dosing schedule for delivering the drug to the patient, with further dependence on the additional sensor data. Obtaining additional sensor data using the additional sensor may include at least one of the following: obtaining additional sensor data related to the patient's condition using a patient monitoring sensor, obtaining additional sensor data related to the drug administration device using a sensor of the device, obtaining additional sensor data related to the environment in which the drug administration device is present using an environmental sensor, and obtaining additional sensor data related to the geographic location of the drug administration device using a location sensor.

[0025] In another example, the method may include receiving additional user input data using a user interface, wherein the method may include transmitting the additional user input data to a second drug administration device, and determining a second drug dosing regimen for delivering the drug to a patient may include determining a second drug dosing regimen for delivering the drug to the patient, further depending on the additional user input data. In at least some embodiments, the method may include receiving additional sensor data using an additional sensor, wherein the method may include transmitting the additional sensor data to the second drug administration device, and determining a second drug dosing regimen for delivering the drug to the patient may include determining a second drug dosing regimen for delivering the drug to the patient, further depending on the additional sensor data. Obtaining additional sensor data using an additional sensor may include at least one of the following: obtaining additional sensor data related to a patient's condition using a patient monitoring sensor, obtaining additional sensor data related to a drug administration device using a device sensor, obtaining additional sensor data related to an environment in which the drug administration device is present using an environmental sensor, and obtaining additional sensor data related to a geographic location of the drug administration device using a location sensor.

[0026] In another example, the drug delivery device may be an autoinjector, and determining the first and second drug dosing schedules includes specifying one or more of the following: a depth of advancement of the outlet port during drug delivery to the patient, a velocity of the outlet port during drug delivery to the patient, and an acceleration of the outlet port during drug delivery to the patient. In another example, the drug delivery device may be an inhaler. In another example, the drug delivery device may be an infusion pump.

[0027] In another example, the method may include transmitting dosing data from a computer system to a drug administration device and determining on the drug administration device a first drug dosing schedule for delivering a drug to a patient depending on the dosing data. In another example, the first and second drug dosing schedules may indicate one or more of the following drug dosing parameters: a drug delivery rate, a drug volume, and a drug delivery duration, and the value of one or more parameters in the first drug dosing schedule differs from the value of the corresponding parameter in the second drug dosing schedule.

[0028] In another example, the medicament may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0029] In another embodiment, a method for determining a drug dosing regimen for delivering a drug to a patient includes delivering a drug to the patient in accordance with a first drug dosing regimen using a drug administration device; receiving user input data using a user interface; determining on the drug administration device a second drug dosing regimen for delivering a drug from the drug administration device to the patient depending on the user input data and dosing data from a computer system; and delivering the drug to the patient in accordance with the second drug dosing regimen using the drug administration device.

[0030] The method may vary in any number of ways. For example, the method may include determining on the drug administration device a first drug dosing schedule for delivering the drug to the patient before delivering the drug to the patient in accordance with the first drug dosing schedule. In another example, the method may include obtaining sensor data using a sensor and determining a second drug dosing schedule for delivering the drug to the patient, with further dependence on the sensor data.

[0031] In another example, each of the first and second drug dosing regimens may indicate at least one of a drug administration rate, a drug volume, and a drug delivery duration. In another example, obtaining sensor data using a sensor includes at least one of the following: obtaining sensor data related to a patient condition using a patient monitoring sensor, obtaining sensor data related to a drug administration device using a sensor of the device, obtaining sensor data related to an environment in which the drug administration device is present using an environmental sensor, and obtaining sensor data related to a geographic location of the drug administration device using a location sensor. In another example, the method may include obtaining external sensor data using an external sensor, and determining a second drug dosing regimen for delivering the drug to the patient may include determining a second drug dosing regimen with further dependence on the external sensor data. In another example, the method may include obtaining additional sensor data using an additional sensor, wherein the method may include transmitting the additional sensor data to a second drug delivery device, and determining a second drug dosing schedule for delivering the drug to the patient may include determining a second drug dosing schedule for delivering the drug to the patient with further dependence on the additional sensor data. Obtaining additional sensor data using the additional sensor may include at least one of the following: obtaining additional sensor data related to the patient's condition using a patient monitoring sensor, obtaining additional sensor data related to the drug administration device using a sensor of the device, obtaining additional sensor data related to the environment in which the drug administration device is present using an environmental sensor, and obtaining additional sensor data related to the geographic location of the drug administration device using a location sensor.

[0032] In another example, the method may include receiving additional user input data using a user interface, wherein the method may include transmitting the additional user input data to a second drug administration device, and determining a second drug dosing regimen for delivering the drug to a patient may include determining a second drug dosing regimen for delivering the drug to the patient, further depending on the additional user input data. In at least some embodiments, the method may include receiving additional sensor data using an additional sensor, wherein the method may include transmitting the additional sensor data to the second drug administration device, and determining a second drug dosing regimen for delivering the drug to a patient may include determining a second drug dosing regimen for delivering the drug to the patient, further depending on the additional sensor data. Obtaining additional sensor data using an additional sensor may include at least one of the following: obtaining additional sensor data related to a patient's condition using a patient monitoring sensor, obtaining additional sensor data related to a drug administration device using a device sensor, obtaining additional sensor data related to an environment in which the drug administration device is present using an environmental sensor, and obtaining additional sensor data related to a geographic location of the drug administration device using a location sensor.

[0033] In another example, the drug delivery device may be an autoinjector, and determining the first and second drug dosing schedules includes specifying one or more of the following: a depth of advancement of the outlet port during drug delivery to the patient, a velocity of the outlet port during drug delivery to the patient, and an acceleration of the outlet port during drug delivery to the patient. In another example, the drug delivery device may be an inhaler. In another example, the drug delivery device may be an infusion pump.

[0034] In another example, the method may include transmitting dosing data from a computer system to a drug administration device and determining on the drug administration device a first drug dosing schedule for delivering a drug to a patient depending on the dosing data. In another example, the first and second drug dosing schedules may indicate one or more of the following drug dosing parameters: a drug delivery rate, a drug volume, and a drug delivery duration, and the value of one or more parameters in the first drug dosing schedule differs from the value of the corresponding parameter in the second drug dosing schedule.

[0035] In another example, the medicament may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

BRIEF DESCRIPTION OF DRAWINGS

[0036] The present invention is described with reference to the accompanying figures:

[0037] Fig. 1 shows a schematic view of a device for administering a drug of the first type, namely an autoinjector;

[0038] Fig. 2 shows a schematic view of a device for administering a second type of drug, namely an infusion pump;

[0039] Fig. 3 shows a schematic view of a device for administering a drug of a third type, namely an inhaler;

[0040] Fig. 4 is a schematic view of a device for administering a fourth type of drug, namely a nasal spray device;

[0041] Fig. 5A is a schematic view of a general device for administering a drug;

[0042] Fig. 5B is a schematic view of a universal device for administering a drug;

[0043] Fig. 6 shows a schematic view of the housing for the dosage form;

[0044] Fig. 7 is a schematic view of one embodiment of a network communication system with which the drug delivery devices and housing may operate;

[0045] Fig. 8 is a schematic view of one embodiment of a computer system that can operate the drug delivery devices and housing;

[0046] Fig. 9 is a schematic view of one embodiment of a drug delivery system.

[0047] Fig. 10A is a schematic view of another embodiment of a device for administering a drug;

[0048] Fig. 10B is a schematic graph showing data obtained by the sensors of the embodiment shown in Fig. 10A;

[0049] FIG. 11A is a schematic view of another embodiment of a drug delivery device;

[0050] Fig. 11B is a schematic graph showing data obtained by the sensors of the embodiment shown in Fig. 11A;

[0051] FIG. 12A is a schematic view of another embodiment of a drug delivery device;

[0052] Fig. 12B is a schematic graph showing data obtained by the sensors of the embodiment shown in Fig. 12A;

[0053] FIG. 13A is a schematic view of another embodiment of a drug delivery device;

[0054] Fig. 13B is a schematic graph showing data obtained by the sensors of the embodiment shown in Fig. 13A;

[0055] FIG. 14 is a schematic view of another embodiment of a drug delivery device;

[0056] FIG. 15 is a schematic view of another embodiment of a drug delivery device;

[0057] Fig. 16A is a schematic view of one embodiment of a drug delivery device including a temperature sensor and

[0058] FIG. 16B is an end view of the drug delivery device of FIG. 16A.

DETAILED DESCRIPTION

[0059] In order to provide a complete understanding of the principles of construction, operation, manufacture and use of the devices, systems and methods described herein, a description of certain embodiments is given below. One or more examples of these embodiments are shown in the accompanying drawings. It will be understood by one skilled in the art that the specific devices, systems and methods described herein and illustrated in the accompanying drawings are embodiments that are not limiting in nature, and that the scope of the present invention is defined only by the claims. Features illustrated or described in connection with one embodiment can be combined with features of other embodiments. It is intended that the scope of the present invention includes such modifications and variations.

[0060] Furthermore, in the present description, similar components of embodiments have substantially similar features, and thus, within a particular embodiment, each feature of each similar component is not necessarily fully described. Furthermore, to the extent that linear or circular shapes and dimensions are used in the description of the systems, devices and methods of the invention, such linear or circular shapes and dimensions are not intended to limit the types of shapes that can be used in combination with such systems, devices and methods. One skilled in the art will understand that the equivalent of such linear or circular shapes and dimensions can be easily determined for any geometric figure. One skilled in the art will understand that the size and shape may not have an exact value, but are nevertheless believed to have approximately such a value due to a variety of factors, such as manufacturing tolerances and the sensitivity of measuring equipment. The sizes and shapes of the systems and devices and their components can depend at least on the size and shape of the components with which the systems and devices will be used.

[0061] Examples of various types of devices for administering a drug, namely: an autoinjector 100, an infusion pump 200, an inhaler 300 and a nasal spray device 400 are described below with reference to the above figures.

Autoinjector

[0062] Fig. 1 shows a schematic example of a view of a device for administering a first type of drug, namely an injection device, in this example an autoinjector 100 suitable for use with the embodiments described in this document. The autoinjector 100 comprises a drug holder 110 that holds a drug to be delivered, and a delivery mechanism 120 configured to deliver the drug from the drug holder 110 so that it can be administered to a patient. The drug holder 110 is typically in the form of a container containing the drug, for example, it can be in the form of a syringe, or a vial, or any other suitable container in which the drug can be contained. The autoinjector 100 comprises an outlet channel 122, for example a syringe needle, which is located at the distal end of the drug holder 110. The feed mechanism 120 comprises a drive element 124, which may comprise a piston and/or a piston rod and a drive mechanism 126. The feed mechanism 120 is located proximally to the end of the drug holder 110 and closer to the proximal end of the autoinjector 100.

[0063] The autoinjector 100 comprises a housing 130 that comprises a drug holder 110, a drive element 124, and a drive mechanism 126 within the housing 130, and also comprises an outlet channel 122 that is typically completely contained within the housing prior to injection, but that extends from the housing 130 during an injection sequence to administer the drug. The delivery mechanism 120 is arranged such that the drive element 124 moves through the drug holder 110 to deliver the drug through the outlet channel 122, thereby allowing the autoinjector to administer the drug held in the drug holder 110 to the patient. In some cases, the user may advance the drive element 124 through the drug holder 110 manually. In other cases, the drive mechanism 126 may include a power source 127 that advances the drive element 124 automatically. The energy source 127 may include an elastic biasing element such as a spring or pressurized gas, or an electrically powered motor and/or gearbox.

[0064] The autoinjector 100 includes a feed mechanism protection mechanism 140. The feed mechanism protection mechanism 140 typically has two functions. First, the feed mechanism protection mechanism 140 can prevent access to the outlet channel 122 before and after injection. Second, the autoinjector 100 can operate such that when transferred to the activated state, the feed mechanism protection mechanism 140 moves to an unlocked position, wherein the feed mechanism 120 can be activated.

[0065] The protection mechanism 140 covers at least a portion of the outlet channel 122 when the medicine holder 110 is in a retracted position proximally within the housing 130. This should prevent contact between the outlet channel 122 and the user. Alternatively or in addition, the protection mechanism 140 itself is configured to be retracted in the proximal direction to expose the outlet channel 122 so that it can be brought into contact with the patient. The protection mechanism 140 comprises a protective element 141 and a return spring 142. The return spring 142 serves to pass the protective element 141 from the housing 130, thereby covering the outlet channel 122, when a force is applied to the distal end of the protection mechanism 140. If the user applies force to the protective element 141, counteracting the action of the return spring 142, in order to overcome the bias of the return spring 142, the protective element 141 is retracted into the housing 130, thereby exposing the outlet channel 122. The protection mechanism 140 may alternatively or additionally comprise an expansion mechanism (not shown) for passing the outlet channel 122 outside the housing 130 and may additionally comprise a retraction mechanism (not shown) for retracting the outlet channel 122 inside the housing 130. The protection mechanism 140 may alternatively or additionally comprise a cap cover and/or an outlet channel housing, which can be attached to the autoinjector 100. Removing the housing cover, as a rule, also leads to the removal of the outlet channel housing from the outlet channel 122.

[0066] The autoinjector 100 also includes an actuation mechanism 150. The actuation mechanism 150 comprises a trigger button 151, which is located on the outer surface of the housing 130 so that it is accessible to the user of the autoinjector 100. When the user presses the actuation mechanism 150, it releases the drive mechanism 126, so that, with the help of the drive element 124, the medicine is pushed out of the holder of the medicine PO through the outlet channel 122.

[0067] The actuation mechanism 150 may also cooperate with the protective element 141 such that the actuation mechanism 150 is prevented from being activated until the protective element 141 is retracted in close proximity to the housing 130 in an unlocked position, for example, by pushing the distal end of the protective element 141 toward the patient's skin. When this is done, the actuation mechanism 150 is unlocked and the autoinjector 100 is activated so that the actuation mechanism 150 can be pressed, after which the injection and/or drug delivery sequence is initiated. Alternatively, retracting the protective element 141 separately in a proximal direction into the housing 130 can activate the drive mechanism 126 and initiate the drug administration and/or delivery sequence. Thus, the autoinjector 100 has a mechanism for preventing the operation of the device, which prevents the delivery of the drug, for example, by preventing the accidental release of the delivery mechanism 120 and/or the accidental activation of the actuation mechanism 150.

[0068] Although the above description relates to one example of an auto-injector, this example is presented for illustrative purposes only, and the present invention is not limited to only such an auto-injector. It will be understood by one skilled in the art that various modifications of the described auto-injector can be implemented within the scope of the present description.

[0069] The autoinjectors of the present invention can be used to administer any of a variety of drugs, such as epinephrine, rebif, enbrel, aranesp, atropine, pralidoxime chloride, and diazepam.

Infusion pump

[0070] In other cases, patients may require precise, continuous delivery of a drug, or delivery of a drug on a regular or frequent basis at predetermined periodic intervals. Infusion pumps can provide such controlled drug infusion by facilitating the administration of a drug at a precise rate that maintains the drug concentration in the therapeutic range without requiring constant attention from the healthcare professional or the patient.

[0071] Fig. 2 shows a schematic example of a view of a second type of drug delivery device, namely an infusion pump 200, suitable for use with the embodiments described herein. The infusion pump 200 comprises a drug holder 210 in the form of a reservoir for delivering a drug and a delivery mechanism 220 comprising a pump 216 configured to deliver a drug contained in the reservoir so that the drug can be administered to a patient. These components of the infusion pump are located inside a housing 230. The delivery mechanism 220 further comprises an infusion line 212. The drug is delivered from the reservoir upon activation of the pump 216 via the infusion line 212, which can be in the form of a cannula. The pump 216 may be in the form of an elastomeric pump, a peristaltic pump, an osmotic pump, or a motor-driven piston in a syringe. Typically, the drug is delivered intravenously, although subcutaneous, arterial, and epidural infusions may also be used.

[0072] The infusion pumps of the present invention can be used to administer any of a variety of drugs, such as insulin, atropine sulfate, avibactam sodium, bendamustine hydrochloride, carboplatin, daptomycin, epinephrine, levetiracetam, oxaliplatin, paclitaxel, pantoprazole sodium, treprostinil, vasopressin, voriconazole, and zoledronic acid.

[0073] The infusion pump 200 further comprises a control circuit, such as a processor 296 in addition to a memory 297 and a user interface 280, which together provide a trigger and/or a dose selector for the pump 200. The user interface 280 may be implemented as a display screen located on the housing 230 of the infusion pump 200. The control circuit and user interface 280 may be located inside the housing 230 or outside it and communicate via a wired or wireless interface with the pump 216 to control its operation.

[0074] The actuation of the pump 216 is controlled by a processor 296, which is connected to the pump 216 to control the operation of the pump. The processor 296 can be programmed by a user (e.g., a patient or a health care professional) via a user interface 280. This allows the infusion pump 200 to deliver a drug to the patient in a controlled manner. The user can enter parameters such as the duration of the infusion and the delivery rate. The delivery rate can be set by the user as a constant infusion rate or at set intervals for periodic delivery, typically within preprogrammed values. The programmed parameters for controlling the pump 216 are stored and retrieved from a memory device 297, which is connected to the processor 296. The user interface 280 can take the form of a touch screen or a keyboard.

[0075] Power source 295 provides power to pump 216 and may be in the form of a power source that is an integral part of pump 216 and/or a mechanism for connecting pump 216 to an external power source.

[0076] The infusion pump 200 may have various physical forms depending on its purpose. It may be a stationary, non-portable device, such as for use at the patient's bedside, or it may be an ambulatory infusion pump intended to be moved or carried. The integral power source 295 is particularly useful for an ambulatory infusion pump.

[0077] Although the above description relates to one example of an infusion pump, this example is provided for illustrative purposes only. The present description is not limited to such an infusion pump. One skilled in the art will appreciate that various modifications to the described infusion pump may be implemented within the scope of the present description. For example, the processor may be pre-programmed so that the infusion pump includes a user interface.

Inhaler

[0078] Fig. 3 shows a schematic view of a device for administering a third type of drug, namely an inhaler 300. The inhaler 300 includes a drug holder 310 in the form of a container. The drug holder 310 contains a drug, which, as a rule, can be in a solution or suspension with a suitable carrier liquid. The inhaler 300 further includes a feed mechanism 320, which includes a pressurized gas for increasing the pressure of the drug holder 310, a valve 325 and a nozzle 321. The valve 325 forms an outlet channel of the drug holder 310. The valve 325 comprises a narrow opening 324 formed in the medicine holder 310 and a movable element 326 which controls the opening 324. When the movable element 326 is in the rest position, the valve 325 is in a closed or inactive state, in which the opening 324 is closed, and the medicine holder 310 is hermetically sealed. When the movable element 326 is actuated from the rest position to the driving position, the valve 325 is actuated to an open state, in which the opening 324 is open. Bringing the movable element 326 from the rest position to the driving position includes moving the movable element 326 into the medicine holder 310. The movable element 326 is elastically biased into the rest position. In the open state of the valve 325, the gas under pressure pushes the medicine in the form of a solution or suspension with a suitable liquid from the medicine holder 310 through the opening 324 at a high speed. The high-speed passage of liquid through the narrow opening 324 causes the liquid to be atomized, i.e., the bulk liquid is converted into a mist of fine liquid droplets and/or a gas cloud. The patient can inhale the mist of fine droplets and/or the gas cloud through the respiratory tract. Thus, the inhaler 300 is able to deliver the drug held inside the drug holder 310 to the respiratory tract of the patient.

[0079] The medicine holder 310 is removable and is secured inside the housing 330 of the inhaler 300. The channel 333 formed in the housing 330 connects the first opening 331 in the housing 330 and the second opening 332 in the housing 330. The medicine holder 310 is mounted inside the channel 333. The medicine holder 310 is configured to slide through the first opening 331 of the housing 330 into the channel 333. The second opening 332 of the housing 330 forms an oral mouthpiece 322 configured to be placed in the oral cavity of the patient or a nasal adapter configured to be placed in the nasal opening of the patient, or a mask configured to be placed over the oral cavity and nose of the patient. The medicine holder 310, the first opening 331 and the channel 333 are sized such that air can flow through the channel 333 around the medicine holder 310 between the first opening 331 and the second opening 332. The inhaler 300 can be provided with a mechanism 140 for protecting the delivery mechanism in the form of a cap (not shown), which can be mounted on the mouthpiece 322.

[0080] The inhaler 300 further comprises an actuation mechanism 350 comprising a valve actuator 355 configured to actuate the valve 325 upon activation of the actuation mechanism 350. The valve actuator 355 is a projection of the housing 330 into the channel 333. The medicine holder 310 is configured to slide within the channel 333 from a first position to a second position. In the first position, the end of the movable element 326 in the rest position rests against the valve actuator 355. In the second position, the medicine holder 310 can be biased toward the valve actuator 355 such that the valve actuator 355 moves the movable element 326 into the medicine holder 310 to actuate the valve 325 into an open state. The user's hand creates the necessary force to move the holder 310 of the drug from the first position to the second position relative to the elastically biased movable element 326. The actuator 355 of the valve comprises an inlet opening 356, which is connected to the nozzle 321. The inlet opening 356 of the actuator 355 of the valve has a size and location for connection with the opening 324 of the valve 325 in such a way that the injected mist of droplets and/or gas cloud can enter the inlet opening 356 and exit from the nozzle 321 into the channel 333. The nozzle 321 helps to atomize the main mass of the liquid into a mist of droplets and/or gas cloud.

[0081] The valve 325 provides a metering mechanism 370. The metering mechanism 370 is configured to close the valve after a measured amount of liquid and therefore the drug has passed through the opening 324. This allows a controlled dose to be administered to the patient. Typically, the metered amount of liquid is preset, but the inhaler 300 may be equipped with a dosage selector 360 that can be controlled by the user to change the set amount of liquid.

[0082] Although the above description relates to one specific example of an inhaler, this example is illustrative only. The description should not be considered as limited to only such an inhaler. One skilled in the art will appreciate that many other types of inhalers and nebulizers can be used in the present description. For example, the drug can be in powder form, the drug can be in liquid form, or the drug can be nebulized by other forms of delivery mechanism 320, including ultrasonic vibration, compressed gas, a vibrating mesh, or a heat source.

[0083] The inhalers of the present invention can be used to administer any of a variety of drugs, such as mometasone, fluticasone, ciclesonide, budesonide, beclomethasone, vilanterol, salmeterol, formoterol, umeclidinium, glycopyrrolate, tiotropium, aclidinium, indacaterol, salmeterol, and olodaterol.

Spray device for nasal use

[0084] Fig. 4 is a schematic view of a fourth type of drug administration device, namely, a nasal nebulizer device 400. The nasal nebulizer device 400 is configured to deliver a drug to the nose of a patient. The nasal nebulizer device 400 includes a drug holder 402 configured to retain the drug therein for delivery to the patient from the device 400. The drug holder 102 may have a variety of configurations, such as a bottle reservoir, a cartridge, a vial (as in this illustrated embodiment), a blow-fill-seal (BFS) capsule, a blister pack, etc. In an exemplary embodiment, the drug holder 402 is a vial. The exemplary vial is made of one or more materials, such as glass, polymer(s), etc. In some embodiments, the vial may be made of glass. In other embodiments, the vial may be formed from one or more polymers. In other embodiments, various portions of the vial may be formed from different materials. An exemplary vial may include various features to facilitate sealing and storing the drug therein, as described herein and shown in the drawings. However, one skilled in the art will appreciate that vials may include only some of these features and/or may include a number of other features known in the art. The vials described herein are intended to represent specific embodiments only.

[0085] The opening 404 of the nasal spray device 400, through which the drug exits the nasal spray device 400, is formed in the metering head 406 of the nasal spray device 400 in the tip 408 of the metering head 406. The tip 408 is configured to be inserted into the nasal opening. In an illustrative embodiment, the tip 408 is configured to be inserted into a first nostril of a patient during a first stage of operation of the nasal spray device 400 and into a second nostril of a patient during a second stage of operation of the nasal spray device 400. The first and second stages of operation include two separate actuations of the nasal spray device 400, wherein the first actuation corresponds to a first dose of the drug being delivered, and the second actuation corresponds to a second dose of the drug being delivered. In some embodiments, the nasal spray device 400 is configured to be activated only once to deliver one dose of nasal spray. In some embodiments, the nasal spray device 400 is configured to be activated three or more times to deliver three or more doses of nasal spray, such as four, five, six, seven, eight, nine, ten, etc.

[0086] The dosing head 406 comprises a depth guide 410 configured to contact the skin of the patient between the first and second nostrils of the patient, so that the longitudinal axis of the dosing head 406 is substantially aligned with the longitudinal axis of the nostril into which the tip 408 is inserted. One skilled in the art will appreciate that the longitudinal axes may not be precisely aligned, but are nonetheless considered to be substantially aligned due to a variety of factors such as manufacturing tolerances and the sensitivity of the measuring equipment.

[0087] In an illustrative embodiment, as shown in Fig. 4, the dosing head 406 has a conical shape in which the dosing head 406 has a smaller diameter at its distal end than at its proximal end, where the opening 404 is located. The opening 404, having a relatively small diameter, facilitates the spraying of the drug from the opening 404, as will be understood by one skilled in the art. A spray chamber 412, through which the drug must pass before exiting the opening 404, is located in the proximal portion of the conical dosing head 406, distal to the opening 404. When the drug passes through the spray chamber 412 at a speed, the spray chamber 412 helps to form a fine mist, which exits through the opening 404 in the form of a spray. Arrow 414 in Fig. 4 illustrates the path of movement of the drug from the drug holder 402 and from the opening 404.

[0088] In some embodiments, the dosing head 406 may comprise two tips 408, each of which has an opening 404, such that the nasal spray device 400 is configured to simultaneously deliver doses of medication to two nostrils in response to a single actuation.

[0089] The dosing head 406 is configured to be pressed against the medication holder 402, such as by a user pressing the depth guide 410, to actuate the nasal spray device 400. In other words, the dosing head 406 is configured as an actuator that is actuated to deliver medication from the medication holder 402 and from the nasal spray device 400. In an illustrative embodiment, the nasal spray device 400 is configured to be self-administered, so that the user actuating the nasal spray device 400 is a patient receiving medication from the nasal spray device 400, and the actuation of the nasal spray device 400 to deliver medication to the patient can be performed by another person.

[0090] The actuation, such as pressing down on the dosing head 406, is configured to provide air for ventilation into the medication holder 402, as shown by the arrow 416 in Fig. 4. Air entering the medication holder 402 displaces the medication into the medication holder through the tube 418 and then into the dosing chamber 420, which displaces the medication proximally through the cannula 422 through the spray chamber 412 and then out of the opening 404. In response to the release of the dosing head 406, such as when the user stops pressing down on the dosing head 406, the bias spring 426 returns the dosing head 406 to the initial rest position in order to position the dosing head 406 relative to the medication holder 402 for subsequent actuation and delivery of the medication.

[0091] Although the above description relates to one specific example of a nasal spray device, this example is illustrative only. The description should not be construed as limiting only to such a nasal spray device. One skilled in the art will appreciate that the nasal spray device 400 may include various elements in various embodiments depending on various requirements. For example, the nasal spray device 400 may not include the depth guide 410 and/or may include any one or more device indicators, a sensor, a communication interface, a processor, a memory device, and a power source.

[0092] The nasal nebulizer devices described herein can be used to administer any of a variety of drugs, such as ketamine (e.g., Ketalar®), esketamine (e.g., Spravato®, Ketanest®, and Ketanest-S®), naloxone (e.g., Narcan®), and sumatriptan (e.g., Imitrex®).

Device for administering a medicinal product

[0093] As follows from the above, various components of drug delivery devices are common to all such devices. These components are the main components of a universal drug administration device. The drug administration device delivers a drug to a patient, wherein the drug is provided in a specific dosage form within the drug administration device.

[0094] Fig. 5A shows a generalized schematic view of such a universal device 501 for administering a drug, and Fig. 5B shows an example of an embodiment of such a universal device 500 for administering a drug. Examples of a universal device 500 for administering a drug include injection devices (e.g., auto-injectors, jet injectors, and infusion pumps), nasal spray devices, and inhalers.

[0095] As shown in Fig. 5A, the device 501 for administering a drug generally includes elements of a drug holder 10 and a delivery mechanism 20. The drug holder 10 contains a drug in a dosage form to be administered. The delivery mechanism 20 is configured to release the dosage form from the drug holder 10 so that the drug can be administered to a patient.

[0096] Fig. 5B shows an additional universal device 500 for administering a drug that includes a number of additional elements. One skilled in the art will understand that these additional elements are optional for various embodiments and can be used in various combinations, so that the additional elements may or may not be present in a given embodiment of a particular device for administering a drug depending on requirements such as the type of drug, the dosage form of the drug, the medical indication for treatment with the drug, safety requirements, whether the device is portable, whether the device is used for self-administration, and many other requirements that will be understood by one skilled in the art. Similar to the universal device shown in Fig. 5A, the device 500 for administering a drug includes a housing 30 that accommodates a holder 10 of the drug and a delivery mechanism 20.

[0097] The device 500 is provided with a trigger 50 for initiating the release of the drug from the drug holder 10 by the delivery mechanism 20. The device 500 includes a measuring/dosing mechanism element 70 that measures a predetermined dose for releasing the drug from the drug holder 10 through the delivery mechanism 20. Thus, the device 500 for administering the drug can provide a known dose of a certain volume. The device 500 includes a dosage selector 60 that allows the user to set the volume of the drug to be measured by the measuring mechanism 50. The dose volume can be set to one specific value from a plurality of predetermined discrete dose volumes or to any value of the predetermined dose volume within a range of dose volumes.

[0098] The device 500 may comprise a mechanism 40 or 25 for preventing the device from being triggered, which in the fixed state prevents and/or stops the delivery mechanism 20 from releasing the drug from the drug holder 10, which in the unlocked state will allow the delivery mechanism 20 to release a dose of the drug from the drug holder 10. This may prevent accidental administration of the drug, for example, to prevent dosing at the wrong time or to prevent unintentional triggering. The device 500 also comprises a mechanism 42 for protecting the delivery mechanism, which prevents access to at least a part of the delivery mechanism 20, for example, for safety reasons. The mechanism 40 for preventing the device from being triggered and the mechanism 42 for protecting the delivery mechanism may be the same component.

[0099] The device 500 may include a device indicator 85 that is configured to present information about the state of the device for administering a drug and/or the drug contained therein. The device indicator 85 may be a visual indicator, such as a display device or an audio indicator. The device 500 comprises a user interface 80 that may be configured to present information about the device 500 to a user of the device 500 and/or to provide the ability to control the device 500. The device 500 includes a device sensor 92 that is configured to receive information related to the device for administering a drug and/or the drug contained therein, such as the dosage form and the parameters of the device. As an example, in embodiments that include a dosing mechanism 70 and a dosage selector 60, the embodiment may further include one or more sensors 92 of the device configured to determine one or more of: a dose selected by the user using the dosage selector 60, a dose metered by the dosing mechanism 70, and a dose delivered by the delivery mechanism 20. Similarly, an environmental sensor 94 may be provided, configured to measure information related to the environment in which the device 500 operates, such as ambient temperature, ambient humidity, location and time. A special location sensor 98 may be provided, configured to determine the geographic location of the device 500, such as by means of satellite location, such as GPS. The device 500 may also include a communication interface 99, which can transmit externally data obtained from various sensors about the device and/or the drug.

[00100] If necessary, the device 500 comprises a power source 95 for supplying electrical energy to one or more electrical components of the device 500. The power source 95 may be a power source integrated into the device 500 and/or a mechanism for connecting the device 500 to an external power source. The device 500 for administering a drug also includes a computer system 90 of the device, including a processor 96 and a memory device 97 powered by the power source 95 and, optionally, other electrical and control components of the device 500, such as an environmental sensor 94, a location sensor 98, a device sensor 92, a communication interface 99 and/or an indicator 85. The processor 96 is configured to receive data from the environmental sensor 94, the device sensor 92, the communication interface 99, the location sensor 98 and/or the user interface 80 and process the data to obtain output data, for example, for the indicator 85 and/or the communication interface 99.

[00101] In some embodiments, the drug administration device 500 is contained in a housing 35. The housing 35 may further include a combination of a processor 96, a memory 97, a user interface 80, a device indicator 85, a device sensor 92, a location sensor 98, and/or environmental sensors 94, as described herein, and they may be located outside the housing of the device 500.

[00102] It will be understood by one skilled in the art that the universal device 500 for administering a drug, comprising a drug holder 10 and a delivery mechanism 20, may be provided with the various optional elements described above in a number of different combinations. Moreover, the device 500 for administering a drug may comprise more than one drug holder 10, optionally with more than one delivery mechanism 20, so that each drug holder has its own associated delivery mechanism 20.

Dosage forms

[00103] Traditionally, drug delivery devices utilize a liquid dosage form. However, it should be understood that other dosage forms are available.

[00104] One such common dosage form is the tablet. A tablet may be made from a combination of the drug and an excipient pressed together. Other dosage forms include pastes, creams, powders, ear drops, and eye drops.

[00105] Other examples of dosage forms include skin patches, drug-eluting stents, and intrauterine devices. In these examples, the body of the device contains a drug and may be configured to release the drug under certain circumstances. For example, a skin patch may contain a polymeric composition containing a drug. The polymeric composition allows the drug to diffuse from the polymeric composition into the patient's skin. Drug-eluting stents and intrauterine devices may operate in a similar manner. Thus, patches, stents, and intrauterine devices may themselves be considered drug holders with an appropriate dosing mechanism.

[00106] Any of these dosage forms may be configured to initiate drug release under certain conditions. This may ensure drug release at a desired time or location after the dosage form has been administered to a patient. In particular, drug release may be initiated externally. Moreover, these dosage forms may be placed in a housing prior to administration, which may be in the form of a box. This housing may contain some of the optional elements described above that are used with the universal device 500 for administering a drug.

[00107] The drug administered by the drug administration devices of the present invention may be any substance that causes a change in the physiology or psychology of the body when used. Examples of drugs that can be administered using the drug delivery devices of the present invention include 5-alpha-reductase inhibitors, 5-aminosalicylates, 5HT3 receptor antagonists, ACE inhibitors with calcium channel blocking agents, ACE inhibitors with thiazides, adamantane antivirals, adrenal cortex steroids, adrenal corticosteroid inhibitors, adrenergic bronchodilators, agents for acute hypertension, agents for the treatment of pulmonary hypertension, aldosterone receptor antagonists, alkylating agents, allergens, alpha-glucosidase inhibitors, alternative drugs, amoebicides, aminoglycosides, aminopenicillins, aminosalicylates, AMPA receptor antagonists, amylin analogs, combination analgesics, analgesics, androgens and anabolic steroids, angiotensin-converting enzyme inhibitors, angiotensin II inhibitors with calcium channel blockers, angiotensin II inhibitors with thiazides, angiotensin receptor blockers, angiotensin receptor blockers and neprilysin inhibitors, anorectal agents, norexants, antacids, anthelmintics, antiangiogenic ophthalmic agents, monoclonal antibodies to CTLA-4, anti-infectives, monoclonal antibodies to PD-1, antiadrenergic agents (central) with thiazides, antiadrenergic agents (peripheral) with thiazides, antiadrenergic agents, centrally acting, antiadrenergic agents, peripherally acting, antiandrogens, antianginal agents, antiarrhythmic agents, antiasthmatic combinations, antibiotics/antineoplastic agents, anticholinergic antiemetics, anticholinergic antiparkinsonian agents, anticholinergic bronchodilators, anticholinergic chronotropic agents, anticholinergic agents/spasmolytics, anticoagulant reversals, anticoagulants, anticonvulsants, antidepressants, antidiabetic agents, antidiabetic combinations, antidiarrheal agents, antidiuretic hormones, antidotes, antiemetic/antivertigo agents, antifungals, antigonadotropic agents, antigout agents, antihistamines, antihyperlipidemic agents, antihyperlipidemic combinations, antihypertensive combinations, hypouricaemic agents, antimalarial agents, antimalarial combinations, antimalarial quinolones, antimanic agents, antimetabolites, antimigraine agents, antineoplastic combinations, antineoplastic detoxifying agents, antineoplastic interferons, antineoplastic agents, antiparkinsonian agents, antiplatelet agents, antipseudomonal penicillins, antipsoriatics, neuroleptics, antirheumatic agents, antiseptics and germicides, antithyroid agents, antitoxins and antidotes, antituberculosis agents, antituberculosis combinations, antitussives, antiviral agents, antiviral boosters, antiviral combinations, antiviral interferons, anxiolytics, sedatives and hypnotics, aromatase inhibitors, atypical neuroleptics, azole antifungals, bacterial vaccines, barbiturate anticonvulsants, barbiturates, BCR-ABL tyrosine kinase inhibitors, benzodiazepine anticonvulsants, benzodiazepines, beta-blockers with calcium channel blockers channel blockers, thiazide beta blockers, beta blockers, beta-lactamase inhibitors, bile acid sequestrants, biologics, bisphosphonates, bone morphogenetic proteins, bone resorption inhibitors, bronchodilator combinations, bronchodilators, calcimimetics, calcineurin inhibitors, calcitonin, calcium channel blockers, carbamate anticonvulsants, carbapenems, carbapenems/beta-lactamase inhibitors, anticonvulsants, carbonic anhydrase inhibitors, cardiac stressors, cardioselective beta blockers, cardiovascular drugs, catecholamines, cation exchange resins, anti-CD20 monoclonal antibodies, anti-CD30 monoclonal antibodies, anti-CD33 monoclonal antibodies, anti-CD38 monoclonal antibodies, anti-CD52 monoclonal antibodies, CDK inhibitors 4/6, agents acting on the central nervous system, cephalosporins, cephalosporin/beta-lactamase inhibitors, cerumenolytics, CFTR combinations, CFTR potentiators, CGRP inhibitors, chelating agents, chemokine receptor antagonist, chloride channel activators, cholesterol absorption inhibitors, cholinergic agonists, cholinergic myostimulants, cholinesterase inhibitors, CNS stimulants, coagulation modifiers, colony-stimulating factors, contraceptives, corticotropin, coumarins and indanediones, COX-2 inhibitors, decongestants, dermatological agents, diagnostic radiopharmaceuticals, diarylquinolines, dibenzazepine anticonvulsants, digestive enzymes, dipeptidyl peptidase inhibitors 4, diuretics, dopaminergic antiparkinsonian agents, drugs used in alcohol dependence, echinocandins, EGFR inhibitors, estrogen receptor antagonists, estrogens, expectorants, factor Xa inhibitors, anticonvulsants, fatty acid derivatives, fibric acid derivatives, first-generation cephalosporins, fourth-generation cephalosporins, agents for functional bowel disorders, gallstone dissolving agents, gamma-aminobutyric acid analogs, gamma-aminobutyric acid reuptake inhibitors, gastrointestinal agents, general anesthetics, agents acting on the genitourinary system, gastrointestinal stimulants, glucocorticoids, agents that increase glucose levels, glycopeptide antibiotics, platelet glycoprotein receptor inhibitors, glycylcyclines, gonadotropin-releasing hormone, Gonadotropin-releasing hormone antagonists, gonadotropins, group I antiarrhythmics, group II antiarrhythmics, group III antiarrhythmics, group IV antiarrhythmics, group V antiarrhythmics, growth hormone receptor blockers, growth hormones, guanylate cyclase-C agonists, H. pylori eradication agents, H2 antagonists, hedgehog pathway inhibitors, hematopoietic stem cell mobilizers, heparin antagonists, heparins, HER2 inhibitors, herbal products, histone deacetylase inhibitors, hormones, hormonal/antineoplastic agents, hydantoin anticonvulsants, hydrazide derivatives, illicit (street) drugs, immune globulins, immunological agents, immunostimulants, immunosuppressants, anti-impotence agents, in vivo diagnostic biologics, Incretin mimetics, inhaled anti-infectives, inhaled corticosteroids, inotropic agents, insulin, insulin-like growth factors, integrase chain transfer inhibitor, interferons, interleukin inhibitors, interleukins, intravenous nutritional products, iodinated contrast media, ionic iodinated contrast media, iron preparations, ketolides, laxatives, leprostatics, leukotriene modifiers, lincomycin derivatives, local injectable anesthetics, local injectable anesthetics with corticosteroids, loop diuretics, pulmonary surfactants, lymphatic dyes, lysosomal enzymes, macrolide derivatives, macrolides, magnetic resonance imaging contrast media, mast cell stabilizers, medical gas, meglitinides, metabolic agents, methylxanthines, mineralocorticoids, minerals and electrolytes, various agents, various analgesics, various antibiotics, various anticonvulsants, various antidepressants, various antidiabetic agents, various antiemetic agents, various antifungals, various antihyperlipidemic agents, various combinations of antihypertensive agents, various antimalarial agents, various antineoplastic agents, various antiparkinsonian agents, various antipsychotic agents, various antituberculosis agents, various antivirals, various anxiolytics, sedatives and hypnotics, various bone resorption inhibitors, various cardiovascular agents, various central nervous system agents, various coagulation modifiers, various diagnostic dyes, various diuretics, various genitourinary agents, various gastrointestinal agents, various hormones, various metabolic agents, various ophthalmic agents, various otic agents, various respiratory agents, various sex hormones, various topical agents, various unclassified agents, various vaginal agents, mitotic inhibitors, monoamine oxidase inhibitors, oral and throat preparations, mTOR inhibitors, mucolytics, multikinase inhibitors, muscle relaxants, mydriatics, narcotic analgesic combinations, narcotic analgesics, nasal anti-infectives, nasal antihistamines and decongestants, nasal lubricants and washes, nasal preparations, nasal steroids, natural penicillins, neprilysin inhibitors, neuraminidase inhibitors, neuromuscular blockers, neuronal potassium channel openers, new-generation cephalosporins, nicotinic acid derivatives, NK1 receptor antagonists, NNRTIs, non-cardioselective beta-blockers, non-iodinated contrast agents, non-ionic iodinated contrast agents, non-sulfonylureas, non-steroidal anti-inflammatory drugs, NS5A inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), nutraceuticals, foods, ophthalmic anesthetics, ophthalmic anti-infectives, ophthalmic anti-inflammatory agents, ophthalmic antihistamines and decongestants, ophthalmic diagnostic agents, ophthalmic antiglaucoma agents, ophthalmic lubricants and washes, ophthalmic preparations, ophthalmic steroids, ophthalmic steroids with anti-infectives, ophthalmic surgical agents, oral nutritional supplements, other immunostimulants, other immunosuppressants, otic anesthetics, otic anti-infectives, otic preparations, otic steroids, otic steroids with anti-infectives, oxazolidinedione anticonvulsants, oxazolidinone antibiotics, parathyroid hormone and analogues, inhibitors PARP, PCSK9 inhibitors, penicillinase-resistant penicillins, penicillins, peripheral opioid receptor antagonists, mixed peripheral opioid receptor agonists/antagonists, peripheral vasodilators, peripherally acting antiobesity agents, phenothiazine antiemetics, phenothiazine antipsychotics, phenylpiperazine antidepressants, phosphate binders, PI3K inhibitors, plasma expanders, platelet aggregation inhibitors, platelet-stimulating agents, polyenes, thiazide potassium-sparing diuretics, potassium-sparing diuretics, probiotics, progesterone receptor modulators, progestins, prolactin inhibitors, prostaglandin D2 antagonists, protease inhibitors, protease-activated receptor-1 antagonists, proteasome inhibitors, proton pump inhibitors, psoralens, psychotherapeutic agents, psychotherapeutic combinations, purine nucleosides, pyrrole anticonvulsants, quinolones, radiocontrast agents, radiographic additives, radiographic agents, radiographic conjugating agents, radiopharmaceuticals, recombinant human erythropoietins, renin inhibitors, respiratory agents, respiratory inhalation products, rifamycin derivatives, salicylates, sclerosing agents, second-generation cephalosporins, selective estrogen receptor modulators, selective immunosuppressants, selective phosphodiesterase-4 inhibitors, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, serotonergic neuroenteric modulators, sex hormone combinations, sex hormones, inhibitors SGLT-2, skeletal muscle relaxant combinations, skeletal muscle relaxants, smoking cessation agents, somatostatin and somatostatin analogues, spermicides, statins, sterile irrigation solutions, streptogramins, streptomycete derivatives, succinimide anticonvulsants, sulfonamides, sulfonylurea, synthetic ovulation stimulants, tetracyclic antidepressants, tetracyclines, therapeutic radiopharmaceuticals, therapeutic vaccines, thiazide diuretics, thiazolidinediones, thioxanthenes, third-generation cephalosporins, thrombin inhibitors, thrombolytics, thyroid drugs, TNF-alpha inhibitors, tocolytics, topical acne agents, topical agents, topical allergy diagnostics, local anesthetics, local anti-infective agents, topical anti-rosacea agents, topical antibiotics, topical Antifungals, Topical antihistamines, Topical antineoplastics, Topical antipsoriatics, Topical antivirals, Topical astringents, Topical cleansers and depigments, Topical depigmenters, Topical emollients, Topical keratolytics, Topical nonsteroidal anti-inflammatory agents, Topical photochemotherapeutic agents, Topical irritants, Topical steroids, Topical steroids with anti-infectives, Transthyretin stabilizers, Triazine anticonvulsants, Tricyclic antidepressants, Trifunctional monoclonal antibodies, Ultrasound contrast agents, Combination agents for upper respiratory tract diseases, Urea anticonvulsants, Urea cycle disorders, Urinary tract infection agents, Urinary tract antispasmodics, Urine pH modifiers, Uterotonics, Combination vaccines, Vaginal anti-infectives, Vaginal preparations, Vasodilators, vasopressin antagonists, vasopressors, VEGF/VEGFR inhibitors, viral vaccines, viscosity-enhancing supplements, vitamin-mineral combinations, vitamins or VMAT2 inhibitors. The drug administration devices according to the present description can administer a drug selected from epinephrine, Rebif, Enbrel, Aranesp, atropine, pralidoxime chloride, diazepam, insulin, antropine sulfate, avibactam sodium, bendamustine hydrochloride, carboplatin, daptomycin, epinephrine, levetiracetam, oxaliplatin, paclitaxel, pantoprazole sodium, treprostinil, vasopressin, voriconazole, zoledronic acid, mometasone, fluticasone, ciclesonide, budesonide, beclomethasone, vilanterol, salmeterol, formoterol, umeclidinium, glycopyrrolate, tiotropium, aclidinium, indacaterol, salmeterol and olodaterol.

[00108] As mentioned above, any of the various drugs can be delivered using a drug delivery device. Examples of drugs that can be delivered using a drug delivery device as described herein include Remicade® (infliximab), Stelara® (ustekinumab), Simponi® (golimumab), Simponi Aria® (golimumab), Darzalex® (daratumumab), Tremfya® (guselkumab), Eprex® (epoetin alfa), Risperdal Constra® (risperidone), Invega Sustenna® (paliperidone palmitate), Spravato® (esketamine), ketamine, and Invega Trinza® (paliperidone palmitate).

The body of the medicinal product

[00109] As described above, the dosage form may be in a holder that is suitable for the particular dosage form being used. For example, a drug in a liquid dosage form may be in a holder in the form of a vial with a stopper or a syringe with a plunger prior to administration. A drug in a solid or powder dosage form, such as tablets, may be in a housing designed to securely hold the tablets prior to administration.

[00110] The housing may comprise one or a plurality of drug holders, each holder comprising a drug form, for example, the drug may be in the form of a tablet drug form, and the housing may be in the form of a blister pack in which the tablet is held within each of the plurality of holders. The holders are made in the form of recesses in the blister pack.

[00111] Fig. 6 shows a housing 630 that contains a plurality of drug holders 610, each of which contains a dosage form 611. The housing 630 may have at least one environmental sensor 94 configured to receive information related to the environment in which the housing 630 is located, such as the ambient temperature, time, or location. The housing 630 may include at least one device sensor 92 configured to measure information related to the drug of the dosage form 611 contained within the holder 610. A special location sensor 98 may be provided, configured to determine the geographic location of the housing 630, for example, by means of satellite location determination, such as GPS.

[00112] The housing 630 may include an indicator 85 that is configured to provide information about the state of the drug 611 contained in the holder 610 to the user of the drug housing. The housing 630 may also include a communication interface 99 that can transmit information externally via wired or wireless data transmission related to the drug housing 630, the environment, time or location and/or the drug itself.

[00113] If necessary, the housing 630 may comprise a power source 95 for supplying electrical power to one or more electrical components of the housing 630. The power source 95 may be a power source that is an integral part of the housing 630 and/or a mechanism for connecting the housing 630 to an external power source. The housing 630 may also include a computer system 90 of the device that includes a processor 96 and a memory 97 powered by the power source 95 and, optionally, other electrical and control components of the housing 630, such as an environmental sensor 94, a location sensor 98, a device sensor 92, a communication interface 99 and/or an indicator 85. The processor 96 is configured to receive data from the environmental sensor 94, the device sensor 92, the communication interface 99, the location sensor 98 and/or the user interface 80 and process the data to obtain output data, for example, for the indicator 85 and/or the communication interface 99.

[00114] The housing 630 may be in the form of a box. Alternatively, there may be an additional box containing and surrounding the housing 630.

[00115] The holder 610 or additional box may itself contain one or more of the device sensor 92, the environmental sensor 94, the indicator 85, the communication interface 99, the power source 95, the location sensor 98, and the device computer system including the processor 96 and the memory 85, as described above.

Electronic communication

[00116] As noted above, the communication interface 99 may be coupled to the drug administration device 500 or the housing with the drug 630 included in or located on the housing 30, 630, or alternatively within or on the box 35. Such communication interface 99 may be configured to communicate with a remote computer system, such as the central computer system 700 shown in Fig. 7. As shown in Fig. 7, the communication interface 99 associated with the device 500 for administering a drug or the housing 630 is configured to communicate with the central computer system 700 via the communication network 702 from any number of locations, such as a medical facility 706, such as a hospital or other medical center, a home 708 (such as a patient's home or office or a caregiver's home or office), or a mobile location 710. The communication interface 99 may be configured to access the system 700 via a wired and/or wireless connection to the network 702. In an illustrative embodiment, the communication interface 99 shown in Fig. 6 is configured to wirelessly access the system 700, such as via a Wi-Fi connection(s), which may facilitate access to the system 700 from virtually anywhere in the world.

[00117] One skilled in the art will appreciate that the system 700 may include security elements such that aspects of the system 700 accessible to any particular user may be determined based on, for example, the user identifier and/or the location from which the user accesses the system. To this end, each user may have a unique user name, password, biometric data, and/or other security credentials to facilitate access to the system 700. The obtained security parameter information may be checked against a database of authorized users to determine whether the user is authorized and to what extent the user is allowed to interact with the system, view information stored in the system, etc.

Computer system

[00118] As described herein, one or more aspects or elements of the invention described herein, such as components of the central computer system 700, the processor 96, the power supply 95, the memory 97, the communication interface 99, the user interface 80, the device indicators 85, the sensors 92, the state sensors 94 and the location sensors 98, may be implemented in a digital electronic circuit, an integrated circuit, a specially designed application-specific integrated circuit (ASIC), a field programmable gate array (FPGA), firmware, software and/or combinations thereof. These various aspects or elements may include an implementation in one or more computer programs that are executed and/or interpreted on a programmable system that includes at least one programmable processor, which may be special-purpose or general-purpose, coupled to receive and transmit data and instructions to a storage system, to at least one input device and to at least one output device. A programmable system or computer system may include clients and servers. The client and server are typically remote from each other and typically communicate via a communications network, such as the Internet, a wireless wide area network, a local area network, a wide area network, or a wired network. The client-server interaction is made possible by computer programs running on the respective computers, with the client-server communication configured.

[00119] Computer programs, which may also be referred to as programs, software, software applications, applications, components, or code, include machine instructions for a programmable processor and may be implemented in a high-level procedural language, an object-oriented programming language, a functional programming language, a logic programming language, and/or an assembly/machine language. As used herein, the term "machine-readable medium" refers to any computer program product, apparatus, and/or device, such as, for example, magnetic disks, optical disks, storage, and programmable logic devices (PLDs), used to provide machine instructions and/or data for a programmable processor, including a machine-readable medium that receives machine instructions in the form of a machine-readable signal. The term "machine-readable signal" refers to any signal used by a programmable processor to provide machine commands and/or data. The machine-readable medium may permanently store such machine instructions, such as in non-volatile solid-state memory, a magnetic hard disk, or any equivalent storage medium. The machine-readable medium may alternatively or additionally temporarily store such machine instructions, such as in a processor cache or other random-access memory associated with one or more physical processor cores.

[00120] To provide interaction with a user, one or more aspects or elements of the subject matter of the invention described herein, such as the user interface 80 (which may be integrated or independent of the insertion device 500 or the housing 630), may be implemented on a computer having a display device, such as a cathode ray tube (CRT) or a liquid crystal display (LCD) or a light emitting diode (LED) monitor for displaying information to the user. The display device may provide the ability to input information directly (e.g., a touch screen) or indirectly (e.g., via an input device such as a keyboard or voice recognition hardware and software). Other types of devices may also be used to provide interaction with the user. For example, the feedback provided to the user may be any form of sensory feedback, such as visual feedback, auditory feedback, or tactile feedback; and the user input may be in any form, including, but not limited to, acoustic, speech, or tactile form. As described above, this feedback may be provided by one or more indicators 85 of the device in addition to the user interface 80. The indicators 85 of the device may interact with one or more sensor(s) 92 of the device, the environmental sensor(s) 94 and/or the location sensor(s) 98 to provide this feedback or receive input from the user.

[00121] Fig. 8 shows one example of an embodiment of a computer system 700, depicted as a computer system 800. The computer system includes one or more processors 896 configured to control the operation of the computer system 800. The processor(s) 896 may include a microprocessor or central processing unit (CPU), including general-purpose or special-purpose programmable microprocessors and/or any of a variety of proprietary or commercially available single-processor or multi-processor systems. The computer system 800 also includes one or more memory modules 897 configured to provide temporary storage of code for execution by the processor(s) 896 or data received from one or more users, data storage devices, and/or databases. The memory device 897 may include read-only memory (ROM), flash memory, one or more types of random access memory (RAM) (e.g., static RAM (SRAM), dynamic RAM (DRAM), or synchronous DRAM (SDRAM)) and/or a combination of memory technologies.

[00122] Various elements of the computer system are connected to a bus 812. The illustrated bus system 812 is an abstraction that represents any one or more separate physical buses, communication lines/interfaces, and/or multi-drop or point-to-point connections connected by appropriate bridges, adapters, and/or controllers. The computer system 800 also includes one or more network interfaces 899 (also referred to herein as a communication interface), one or more input/output interfaces 880, and one or more data storage devices 810.

[00123] The communication interface(s) 899 are configured to enable the computer system to communicate with remote devices, such as other computer systems and/or devices 500 or housings 630, over a network, and may be, for example, remote desktop connection interfaces, Ethernet adapters and/or other local area network (LAN) adapters. The input/output interface(s) 880 comprises one or more interface components for connecting the computer system 800 to other electronic equipment. For example, the input/output interface(s) 880 may include high-speed data ports, such as universal serial bus (USB) ports, 1394 ports, Wi-Fi, Bluetooth, etc. In addition, the computer system may be accessible to a human user, and thus the input/output interface(s) 880 may include displays, speakers, keyboards, pointing devices, and/or various other video, audio, or alphanumeric interfaces. The data storage device(s) 810 comprises any standard medium for storing data in a non-volatile and/or non-transient mode. Thus, the storage device(s) 810 is configured to store data and/or instructions in a persistent state in which the value(s) is retained despite an interruption in the power supply to the computer system. The data storage device(s) 810 may include one or more hard disks, flash drives, USB drives, optical disks, various media cards, optical disks, compact disks, and/or any combination thereof, and may be directly connected to the computer system or remotely connected to it, such as over a network. In an illustrative embodiment, the data storage device(s) 810 include a tangible or non-volatile computer-readable medium configured to store data, such as a hard disk, flash drive, USB drive, optical disk, media card, floppy disks, or compact disks.

[00124] The elements shown in Fig. 8 may represent some or all of the elements of a single physical machine. Furthermore, not all of the illustrated elements need to be located on or in the same physical machine.

[00125] The computer system 800 may include a web browser for retrieving web pages or other markup language streams, presenting these pages and/or streams (visually, audibly, or otherwise), executing scripts, controls, and other code on these pages/streams, accepting user input with respect to these pages/streams (e.g., to populate input fields), issuing hypertext transfer protocol (HTTP) requests with respect to these pages/streams or otherwise (e.g., to send information from populated input fields to a server), etc. The web pages or other markup language may be hypertext markup language (HTML) or have another traditional form, including embedded extensible markup language (XML), scripts, controls, etc. The computer system 800 may also include a web server for generating and/or transmitting web pages to user computer systems.

[00126] As shown in Fig. 7, the computer system 800 shown in Fig. 8, as described above, can form components of the central computer system 700 that exchange data with one or more computer systems 90 of the device of one or more individual devices 500 or housings for administering a drug 630. Data, such as operating data of the devices 500 or housings 630, medical data of patients obtained by such devices 500 or housings 630, can be exchanged between the central computer system and the system 700, 90 of the device.

[00127] As indicated above, the computer system 800 may also form components of the computer system 90 of the device, which is integrated into the device 500 for administering a drug or the housing 630 or is located in close proximity to it. In this regard, one or more processors 896 correspond to the processor 96, the network interface 799 corresponds to the communication interface 99, the input interface 880 corresponds to the user interface 80, and the memory device 897 corresponds to the memory device 97. In addition, an additional storage device 810 may also be present in the computer system 90 of the device.

[00128] In an embodiment, the computer system 800 can form a computer system 90 of a device in the form of a single unit, for example, contained in one housing 30 of a device for administering a drug, contained in one box 35 for one or more devices 500 for administering a drug, or a housing 630 that contains a plurality of holders 610 of a drug. The computer system 800 can form a central computer system 700 as a single unit as one server or as one tower.

[00129] The single unit may be modular so that various aspects thereof may be replaced and removed as needed, such as for upgrades, replacements, maintenance, etc., without interrupting the functionality of any other aspects of the system. Thus, the single device may also be scalable, with the ability to add additional modules and/or additional functionality of existing modules as needed and/or improved.

[00130] The computer system may also include any of a variety of other software and/or hardware components, including, for example, operating systems and database management systems. Although an illustrative computer system is shown and described herein, it should be understood that this is intended for generality and convenience. In other embodiments, the computer system may differ in architecture and operation from those shown and described herein. In non-limiting examples, the memory device 897 and the storage device 810 may be combined, or the communication interface 899 may be omitted if communication with another computer system is not required.

Implementation options

[00131] It is prudent to monitor compliance with instructions associated with medicinal products that are administered to a patient in different dosage forms. This can ensure that correct procedures are followed and avoid the use of incorrect and potentially dangerous approaches. In addition, it is prudent to optimize the administration of the medicinal product to the patient.

[00132] It also appears desirable to provide a drug administration system that does not require a patient to monitor his or her response to a drug dosing regimen and then adjust the drug dosing regimen. It also appears desirable to provide a drug administration system that takes into account factors that influence a patient's response to a drug dosing regimen but that change over time.

[00133] Fig. 9 shows an example of an embodiment of a drug administration system that includes a drug administration device 500 (Fig. 5B and 7) and a computer system 800 (Fig. 8). Specific examples of drug administration devices 500 are described in this document, such as an autoinjector 100 (Fig. 1), an infusion pump 200 (Fig. 2) and an inhalation device 300 (Fig. 3) with other possible methods such as a nasal nebulizer device. The drug administration device 500 includes a communication interface 99 configured to exchange data with a communication interface 899 of the computer system 800. The drug administration system further includes at least one sensor 93 configured to measure a parameter and thus obtain sensor data, and to transmit the sensor data to the drug administration device 500. The device 500 for administering a drug is configured to use a first drug dosing schedule when the drug is delivered to the patient from the device 500 for administering a drug and to determine a second drug dosing schedule for delivering the drug to the patient from the device 500 for administering a drug. The second drug dosing schedule depends on dosing data of the computer system 800 and sensor data obtained from at least one sensor 93. The sensor data can be obtained by the at least one sensor 93 during and/or after delivering the drug in accordance with the first drug dosing schedule. The device 500 for administering a drug is also configured to use the second drug dosing schedule when the drug is delivered to the patient from the device 500 for administering a drug after using the first drug dosing schedule for delivering the drug to the patient from the device 500 for administering a drug.

[00134] The sensor data may relate to the factor(s) that influence the patient's response to the first drug dosing regimen. Thus, the drug delivery system may better optimize the patient's dosing regimen based on the data, without the patient having to monitor and process the data themselves, which may be time-consuming, confusing, and/or impossible due to the inability to accurately measure the factor(s).

[00135] The first drug dosing regimen may depend on dosing data transmitted to the drug administration device 500 from the computer system 800. This communication allows the first drug dosing regimen to be determined by the computer system 800. Thus, the drug administration device 500 may be configured to determine the first drug dosing regimen for delivering the drug to the patient before using the first drug dosing regimen when the drug is delivered to the patient. In an alternative embodiment, the first dosing schedule may be a default dosing schedule contained in the drug administration device 500, such as stored in the memory 97. The first dosing schedule may be present on the drug administration device 500 from the time the drug administration device 500 is manufactured or at least during the time before a user (e.g., a patient, a caregiver, or a healthcare professional) receives the drug administration device 500 for use on a patient.

[00136] The dosing data may refer to data that indicates that the drug dosing parameter(s) should be used by the drug administration device 500 when delivering the drug therefrom to a patient. In this way, the dosing data may be used as a basis for determining a first drug dosing regimen. The drug dosing regimen is a set of one or more drug dosing parameters associated with drug delivery. Examples of drug dosing parameters include at least one of the following: a drug administration rate, a drug volume, a drug delivery duration, a drug delivery frequency, and a drug administration time. As mentioned, each of the first and second drug dosing regimens consists of one or more such drug dosing parameters.

[00137] Each of the first and second dosing regimens is an algorithm stored in the memory 97 of the drug administration device 500, which is an executable module on the board of the drug administration device 500 by the processor 96. The algorithm is stored in the form of one or more sets of multiple data points that define and/or represent instructions, notifications, signals, etc. for controlling the functions of the device 500 and administering the drug from the device 500. As described herein, data received by the drug administration device 500, for example, in the form of a plurality of data points via its communication interface 99, can be used, for example, by the processor 96 to change at least one drug dosing parameter in the algorithm. The at least one drug dosing parameter is included in the number of data points of the algorithm, and thus each of them can be changed by changing one or more stored sets of data points of the algorithm.

[00138] The data received by the drug administration device 500, for example, from the computer system 800 and at least one sensor 93, may identify the drug dosing parameter(s) to change and the updated value of each parameter, or the data received by the drug administration device 500 may include input parameter(s) that the drug administration device 500 is configured to use when performing a calculation (for example, when performing a calculation algorithm stored in the memory 97) to determine the correct value for each drug dosing parameter(s) in the algorithm for the drug dosing schedule. The calculation algorithm is stored in the form of one or more sets of multiples of data points. The calculation algorithm used by the drug administration device 500 may already be present in the memory 97 before receiving the dosing data. In an alternative embodiment, the calculation algorithm used by the device 500 for administering the drug may be represented as part of the dosing data, which also includes the input parameter(s).

[00139] The input parameter(s) that are used as part of the drug dosing parameter determination that includes executing the calculation algorithm may include clinical data such as the patient's age, the patient's weight, the patient's urine pH, the patient's temperature, the patient's condition to be treated, and the presence of other disease states. The input parameters may include data related to the activity or toxicity of the drug, such as the minimum therapeutic dose, the maximum therapeutic dose, and adverse effects. The input parameters may include pharmacokinetic data such as the absorption rate, the distribution rate, the metabolism, and the excretion rate of the particular drug to be delivered to the patient. The drug dosing algorithm may take these parameters as input and calculate a drug dosing schedule.

[00140] After changing at least one drug dosing parameter, subsequent execution of the algorithm results in obtaining another dose of drug in accordance with the algorithm, which reflects the drug dosing regimen, that is, the first drug dosing regimen or the second drug dosing regimen (or the drug dosing regimen after the second drug dosing regimen, since the drug dosing regimen may be changed any number of times to help optimize drug delivery over time). In an alternative embodiment, each changed algorithm, such as each other drug dosing regimen, may be stored in the memory 97 with the processor 96 executing the most recently stored drug dosing regimens to initiate drug delivery from the drug administration device 500. Storing each of the drug dosing regimens may require more memory 97 than if only one drug dosing regimen were stored at a time, but storing each of the drug dosing regimens in memory 97 at a time facilitates analysis of drug delivery, patient compliance, and/or patient treatment.

[00141] By providing changes in the dosage regimen of the drug over time, it can be controlled instead of the patient, for example, by a health care professional providing input for changing the drug delivery to the system 700 in order to improve the positive results of using the drug. Changing at least one drug dosage parameter is automated to improve the patient's treatment results. In this way, the drug administration device can be configured to facilitate personalized medicine dependent on the patient in order to provide an intelligent system for drug delivery.

[00142] As described above, the dosing data may comprise a direct indication of the drug dosing parameter(s) used by the drug administration device 500, or, in an alternative embodiment, the dosing data may comprise an input parameter(s) that is/are used by the drug administration device 500 as part of a determination calculation performed on the drug administration device 500. Either approach allows the drug administration device 500 to modify the drug dosing regimen to improve the efficiency of the drug dosing regimen. Similarly, the sensor data may comprise an indication of the drug dosing parameter(s) that the drug administration device 500 should use, or, alternatively, the sensor data may comprise an input parameter(s) that is used by the drug administration device 500 as part of a determination calculation performed on the drug administration device 500.

[00143] As noted herein, the drug administration device 500 is also configured to determine a second drug dosing regimen. The second drug dosing regimen is calculated based on a plurality of input data, as described above, such as based on dosing data from the computer system 800 and/or sensor data from at least one sensor 93. The plurality of input data may also include user input data that is entered into the drug administration device 500 via the user interface 80. The plurality of input data may be used to adjust the second drug dosing regimen relative to the first drug dosing regimen and, thus, may assist in optimizing the drug dosing regimen for the patient.

[00144] The computer system 800 may be configured to determine a second drug dosing regimen similar to that described above with respect to using the drug administration device to determine the second drug dosing regimen, and the computer system 800 may be configured to send the second drug dosing regimen to the drug administration device 500. In this manner, the drug administration device 500 may have a smaller and/or less expensive memory 97 and/or processor 96 since the drug administration device 500 must be configured to store and execute the second drug dosing regimen without having to receive sensor data or perform any calculations to determine the second drug dosing regimen (other than recognizing that the second drug dosing regimen has replaced the first drug dosing regimen as the current drug dosing regimen). To facilitate the computer system's determination of the second drug dosing regimen, sensor data obtained by at least one sensor 93 during and/or after drug delivery in accordance with the first drug dosing regimen can be transmitted from at least one sensor 93 to the computer system 800, for example, using their communication interfaces. The computer system 800 also has dosing data that can be used to determine the second drug dosing regimen.

[00145] At least one sensor 93 may include one or more different types of sensors and may include one or more sensors of the same type. Examples of sensors that can be used in any combination, since at least one sensor 93 includes a patient monitoring sensor 91 (Fig. PA) configured to receive sensor data related to a patient's condition, a device sensor 92 (Fig. 5B) configured to receive sensor data related to the drug administration device 500 and/or the drug contained therein, a sensor 94 (Fig. 5B) configured to receive sensor data related to the environment in which the drug administration device 500 is present, and a location sensor 98 (Fig. 5B) configured to receive sensor data related to the geographic location of the drug administration device 500. At least one sensor 93 may be part of the drug administration device 500 or, as shown in this illustrated embodiment in Fig. 9, at least one sensor 93 may be a separate element of the drug administration device 500. When at least one sensor 93 comprises a plurality of sensors, one or more sensors may be on a board of the drug administration device 500, and/or one or more sensors may be a separate element of the drug administration device 500.

[00146] The patient monitoring sensor 91 is configured to obtain sensor data related to the patient's condition. The sensor data related to the patient's condition may include any one or more of the following: the patient's blood oxygen level (e.g., using a blood oxygen sensor), the patient's blood glucose level (e.g., using glucose monitoring, etc.), the patient's blood pressure (e.g., using blood pressure monitoring, etc.), the patient's heart rate (e.g., using heart rate monitoring, etc.), the patient's temperature, the patient's metabolic response, the duration and/or severity of an asthma exacerbation, the time of a physiological response to drug administration, the magnitude of the patient's physiological response, tissue thickness, tissue density, and body mass of the patient. For example, impedance sensors are a type of patient sensor that can be used to measure tissue thickness and tissue density.

[00147] The device sensor 92 is configured to obtain sensor data related to the drug administration device 500 and/or the drug contained therein, which in one embodiment may include one or more orientations of the drug administration device 500 (e.g., using a gyrometer, accelerometer, tilt/angle switch (non-mercury), position sensor, etc.) and a temperature of the drug in the drug administration device 500 (e.g., using a temperature sensor such as a thermistor, thermocouple, etc.), since orientation and temperature may be of particular importance to the drug dosing schedule.

[00148] The environmental sensor 94 is configured to obtain sensor data related to the environment in which the drug administration device 500 is present, which in an exemplary embodiment may include a sensor configured to collect one or more sensor data related to the quality of the air in which the device 500 is present (e.g., using a UV sensor, etc.), a pollen count of the environment in which the device 500 is present (e.g., using a pollen sensor, etc.), the humidity of the environment in which the device 500 is present (e.g., using a thermostat, humidifier, hygrometer, etc.), and the temperature in which the device 500 is present (e.g., using a temperature sensor such as a thermistor, thermocouple, etc.). The air quality metrics include measurements of nitrogen dioxide, ground-level ozone, carbon monoxide, and particulate matter.

[00149] The drug administration device 500 may be configured to determine a first drug dosage regimen for delivering a first drug to a patient and to determine a second drug dosage regimen for delivering a second drug to the patient, where the second drug is different from the first drug. The drug administration device 500 may be configured to deliver both the first and second drugs to the patient. For example, the first drug may be a drug for periodic re-therapy and the second drug may be a drug for routine preventive therapy. Drugs suitable for these purposes are known to those skilled in the art. The drug administration device 500 may be configured to adjust each of the first and second drug dosage regimens as described above, so that the delivery of each of the first and second drugs can be optimized for the patient.

[00150] Fig. 10A is a schematic diagram of an example embodiment of the drug administration system shown in Fig. 9. In the embodiment shown in Fig. 10A, the drug administration device 500 is an inhaler 300 (Fig. 3). The sensor 91 (Fig. 9) in this illustrated embodiment of the invention includes a first patient monitoring sensor 91a configured to receive sensor data related to the oxygen level of the patient, a second patient monitoring sensor 9 lb configured to receive data related to the blood pressure (BP) of the patient, a third patient monitoring sensor 91 c configured to receive data related to the heart rate of the patient, an environmental sensor 94 (Fig. 5B) configured to receive data related to the air quality and pollen amount of the environment in which the inhaler 300 is present, and a fourth patient monitoring sensor 9Id configured to receive sensor data related to the body weight (mass) of the patient. In use, the sensors 91a, 91b, 91c, 91d, 94 receive data and report the data to the inhaler 300 as described above.

[00151] Accordingly, as described above in connection with Fig. 9, the inhaler 300 in the embodiment shown in Fig. 10A is configured to use a first drug dosing schedule to deliver drug therefrom to a patient. The inhaler 300 is configured to subsequently determine a second drug dosing schedule to deliver drug therefrom to a patient with a second drug dosing schedule dependent on dosing data from the computer system 800 and sensor data from the patient monitoring sensors 91a, 91b, 91c, 91d and the environmental sensor 94 that are received by the sensors 91a, 91b, 91c, 91d, 94 during and/or after the delivery of drug in accordance with the first drug dosing schedule. The inhaler 300 is also configured to use a second dosage regimen for the drug, where the drug is delivered to the patient at a certain point after delivery in accordance with the first dosage regimen and after determining the second dosage regimen for the drug.

[00152] Fig. 10B is a schematic graph of an example of data obtained by the first patient monitoring sensor 91a, the second patient monitoring sensor 91b, the environmental sensor 94 and the fourth body monitoring sensor 91d in addition to three adjustments of the drug dosing schedule that occur at times indicated by the vertical dotted lines. The first of the adjustments of the drug dosing schedule occurs in response to changes that occur when the patient goes outside while wearing or otherwise having the sensors 91a, 91b, 91c, 91d, 94 (e.g., as part of a smart watch worn by the patient, as part of an implanted device, as part of a sensor attached to the surface of the patient's skin, as part of an inhaler 300 worn by the patient, etc.), and experiences changes in pollen levels and air quality. For this first of the adjustments of the drug dosing schedule, the inhaler 300 is configured to adjust the drug dosing schedule depending on the sensor data that indicates an increased pollen level and a decrease in air quality, for example, due to an increase in the amount of particulate matter, as well as the magnitude of the patient's response to the increased pollen level and air quality, as shown by measurements of the blood oxygen level (which decreases) and blood pressure (which also decreases). Thus, the adjusted drug dosing schedule determines an increased size of the drug dose compared to that for the first drug dosing schedule before the patient goes outside in order to better control the patient's symptoms. The drug dose is not delivered to the patient using any of the first two drug dosing schedules.

[00153] The second of the adjustments of the drug dosing schedule occurs in response to changes that occur when the patient, wearing the sensors 91a, 91b, 91c, 91d, 94 or otherwise having them with them, mows the grass outside (e.g., mows the lawn). For this second adjustment of the drug dosing schedule, the inhaler 300 is configured to adjust the drug dosing schedule depending on the sensor data that indicates an increased pollen level, as well as the magnitude of the patient's response to the increased pollen level and reflects the grass cutting activity, as indicated by measurements of the blood oxygen level (which increases) and blood pressure (which decreases). Thus, the adjusted drug dosing schedule determines an increased drug dose size compared to the immediately preceding drug dosing schedule in order to better control the patient's symptoms. The drug dose is delivered to the patient in accordance with this drug dosing schedule, as shown in the "actual administration" marked on the graph in Fig. 10 V.

[00154] The third of the adjustments of the drug dosing schedule occurs in response to changes that occur at some point after the delivery of the drug dose to the patient (the "actual delivery" marked in the graph of Fig. 10B). For this third adjustment of the drug dosing schedule, the inhaler 300 is configured to adjust the drug dosing schedule depending on sensor data that reflects the delivery of the drug, as indicated by measurements of the blood oxygen level (which increases) and blood pressure (which increases). Thus, the adjusted drug dosing schedule determines a reduced drug dose size compared to the dosing schedule of the immediately preceding drug in order to better control the patient's symptoms. The drug dose is not delivered to the patient using this adjusted drug dosing schedule. The drug dosing schedule may be adjusted at any time after this third adjustment of the drug dosing schedule in order to better control the patient's symptoms.

[00155] Optionally, as described above with respect to Fig. 9, the inhaler 300 may be configured to determine the initial drug dosing schedule in Fig. 10B before the patient goes outside, wherein the initial drug dosing schedule depends on the dosing data.

[00156] In the embodiments shown in Fig. 11A-13B, the comfort and efficiency of the drug dosing regimen may be improved by providing the drug administration device with an adjustment to one or more of the following factors: the depth of advancement of the outlet port during drug delivery to the patient, the velocity of the outlet port during drug delivery to the patient, and the acceleration of the outlet port during drug delivery to the patient.

[00157] The depth of advancement of the outlet channel during drug delivery is the maximum depth to which the outlet channel can enter the patient during the entire drug delivery event, from the moment the outlet channel first enters the patient until the moment the outlet channel exits. For an autoinjector (e.g., the autoinjector 100 shown in Fig. 1), the depth of advancement of the outlet channel of the autoinjector during drug delivery to the patient from the autoinjector may be in the range of 2 mm to 25 mm below the surface of the patient's skin.

[00158] The velocity of the outlet port during drug delivery is the maximum velocity at which the outlet port can move when the outlet port enters the patient during the entire drug delivery event, from the time the outlet port first enters the patient until the time the outlet port exits. For an autoinjector (e.g., the autoinjector 100 shown in Fig. 1), the velocity of the outlet port of the autoinjector during drug delivery to the patient from the autoinjector may be in the range of 0.01 m/s to 0.2 m/s.

[00159] The acceleration of the outlet channel during drug delivery is the maximum acceleration that the outlet channel is designed to withstand during the entire drug delivery event, from the time the outlet channel first enters the patient until the time the outlet channel exits. For an autoinjector (e.g., the autoinjector 100 shown in Fig. 1), the acceleration of the outlet channel of the autoinjector during drug delivery to the patient from the autoinjector may be in the range of 0.002 m/s2 to 0.2 m/s2.

[00160] Fig. 11A is a schematic diagram of an embodiment of a drug administration system that includes a computer system 800 (Figs. 8 and 9), a drug administration device 500 (Figs. 5B, 7 and 9), which in this embodiment includes an autoinjector 100 (Fig. 1) and at least one patient monitoring sensor 91, such as an impedance sensor configured to detect the density and/or thickness of a patient's tissue. The drug administration system is substantially configured and used in a manner similar to that described above with respect to the drug administration system shown in Fig. 9. The sensor 91 may be located, for example, on a portion of the autoinjector 100 that comes into direct contact with the injection site, as shown in Fig. 11A. The first and second drug dosing regimens in this embodiment indicate at least a drug volume and a drug delivery rate, for example, the drug dosing parameters of the drug dosing regimen, which can be changed in the algorithm that determines the drug dosing regimen, are a drug volume and a drug delivery rate.

[00161] Thus, in the embodiment shown in Fig. 11A, the autoinjector 100 is configured to use a first drug dosing schedule when the drug is delivered to the patient, determining a second drug dosing schedule dependent on dosing data of the computer system 800 and sensor data from at least one patient monitoring sensor 91, which includes data related to the density and/or thickness of the patient's tissue. The density of the tissue can affect the pain experienced by the patient during the injection. Therefore, a slower introduction during the injection can be used to reduce the pain during the injection when denser tissue is detected. The tissue can be dense, for example, due to a scar or because the tissue is muscle tissue and not subcutaneous tissue.

[00162] Fig. 11B is a schematic graph of an example of tissue density data obtained by at least one patient monitoring sensor 91 in addition to a drug delivery rate (also referred to herein as a "drug administration rate"). The first dosing schedule may depend on the dosing data. This dosing data may not be based on a specific patient or a specific injection site of the patient, but on an injection into tissue with a predetermined density that corresponds to the density of intact tissue. If the at least one patient monitoring sensor 91 receives data indicating that the patient's tissue has a density higher than a predetermined density, the auto-injector 100 may be configured to determine a second dosing schedule that determines a lower drug delivery rate than the first dosing schedule. In this way, the second drug dosing schedule may improve patient comfort during drug delivery.

[00163] Fig. 12A is a schematic diagram of an embodiment of a drug administration system that includes a computer system 800 (Figs. 8 and 9), a drug administration device 500 (Figs. 5B, 7 and 9), which in this embodiment includes an autoinjector 100 (Fig. 1), and at least one sensor 93 (Fig. 9), which in this illustrated embodiment includes at least one device sensor 92 (Fig. 5B) configured to receive sensor data related to at least a temperature of a drug contained in the autoinjector 100. The drug administration system is substantially configured and used in a manner similar to that described above with respect to the drug administration system shown in Fig. 9. The first and second drug dosing schedules in this embodiment indicate at least a volume of drug and a rate of drug delivery. Accordingly, the autoinjector 100 according to the embodiment shown in Fig. 12A is configured to use a first drug dosing schedule when the drug is delivered to the patient, determining a second drug dosing schedule dependent on dosing data from the computer system 800 and sensor data from at least one sensor 92 of the device. If the drug has been cooled, a slow administration of the drug improves patient comfort if the drug has not had sufficient time to warm up to room temperature before injection.

[00164] Fig. 12B is a schematic diagram of an example of temperature data obtained by at least one sensor 92 of the device in the embodiment shown in Fig. 12A, in addition to the rate of delivery of the drug. The autoinjector 100 is configured to determine a first dosing schedule dependent on dosing data transmitted from the computer system 800, wherein the dosing data is based on an injection of the drug at a predetermined temperature. However, if at least one sensor 92 of the device receives data indicating that the drug is at a temperature below the predetermined temperature, the autoinjector 100 is configured to determine a second dosing schedule that sets a lower rate of delivery of the drug than in the first dosing schedule to improve patient comfort.

[00165] Furthermore, the auto-injector 100 is configured to control the mechanism 40 for preventing the operation of the device (Fig. 5B), for example the protection mechanism of the dosing device 140 (Fig. 1), to prevent the operation of the auto-injector 100 before delivering the medication in accordance with either the first or the second dosing scheme, if at least one sensor 92 of the device detects that the temperature of the medication is above a predetermined high threshold value (the "hot threshold" in Fig. 12B) and/or below a predetermined low threshold value (the "cold threshold" in Fig. 12B), considered painful and/or dangerous for the patient. Examples of such threshold values are an upper temperature limit (predetermined high threshold value) of 55 degrees Celsius and a lower temperature limit (predetermined low threshold value) of 2 degrees Celsius.

[00166] Fig. 13A is a schematic diagram of another embodiment of a drug delivery system that includes a computer system 800 (Figs. 8 and 9), a drug delivery device 500 (Figs. 5B, 7 and 9), which in this embodiment includes an autoinjector 100 (Fig. 1), and at least one sensor 92 of the device (Fig. 5B), which in this illustrated embodiment is configured to receive sensor data related to the temperature of the drug contained in the autoinjector 100. The drug delivery system is substantially configured and used in a manner similar to that described above with respect to the drug delivery system shown in Fig. 9. The first and second drug dosing schedules in this embodiment determine at least a volume of drug and a depth of advancement of the autoinjector needle (e.g., outlet port 122) in delivering the drug to a patient. Accordingly, the autoinjector 100 according to the embodiment shown in Fig. 13A is configured to use the first dosage regimen of the drug, when the drug is delivered to the patient, determines the second dosage regimen of the drug, depending on the dosage data from the computer system 800 and on the sensor data from at least one sensor 92 of the device. The dosage data, in which the first dosage regimen of the drug is based on the delivery of the drug at a predetermined temperature. If the drug contained in the autoinjector 100 is felt as colder than the predetermined temperature and more viscous, inserting the needle to a smaller depth of insertion of the needle into the patient will help to ensure the comfort of the patient. Thus, in this embodiment, if the sensor data related to the temperature of the drug indicates that the temperature is lower than that used to determine the first drug dosing schedule, the drug administration device 100 is configured to determine a depth of penetration of the needle in the drug dosing schedule (for example, in an algorithm that determines the drug dosing schedule) that is shorter than that indicated by the first dosing schedule.

[00167] Fig. 13B is a schematic graph of an embodiment of the sensor data obtained in the embodiments shown in Figs. 12A and 13A, in which the sensor data in the graph shown represents the viscosity of the drug contained in the autoinjector 100. The embodiments shown in Figs. 12A and 13A can be combined such that the drug dosing pattern determines both the drug delivery rate (the embodiment shown in Fig. 12A) and the depth of needle advancement (the embodiment shown in Fig. 13A), so that the drug administration device 500 (the autoinjector 100) is configured to determine a second drug dosing pattern that determines both the drug delivery rate and the depth of needle penetration.

[00168] In another example, the drug administration device 500 (autoinjector 100) and at least one sensor 92 of the device may include an orientation sensor. Thus, if the orientation sensor indicates that the drug administration device 500 is positioned such that the drug delivery rate may be reduced, for example, if the device 500 is raised upward, the drug administration device 500 may be configured to determine a second drug dosing schedule that takes into account this likely delivery rate, for example, by increasing the drug delivery rate to account for the perceived orientation indicating a reduced drug delivery rate.

[00169] Fig. 14 is a schematic diagram of an embodiment of a drug administration system that includes a computer system 800 (Figs. 8 and 9), which in this illustrated embodiment is a smartphone, and a drug administration device 500 includes a communication interface 99 configured to exchange data with a communication interface 899 of the computer system 800. The drug administration system is substantially configured and used in a manner similar to that described above with respect to the drug administration system shown in Fig. 9. The computer system 800 includes at least one user interface 80 configured to receive user data and transmit user input data to the drug administration device 500. The device 500 for administering a drug is configured to use a first drug dosing schedule when the drug is delivered to the patient from the device 500 for administering a drug, determines a second drug dosing schedule for delivering the drug to the patient, which depends on the dosing data of the computer system 800 and the user input data from at least one user interface 80, which are received through the user interface 80 during and/or after the delivery of the drug in accordance with the first drug dosing schedule, and uses the second drug dosing schedule when the drug is delivered to the patient at a certain time after delivery in accordance with the first dosing schedule and after determining the second drug dosing schedule.

[00170] The user input data may relate to factors that influence the patient's response to the first drug dosing regimen and/or the patient's perceived response to the first drug dosing regimen. Thus, the system may better optimize the current drug dosing regimen based on the patient's response and/or the perceived response to drug delivery even without the ability to use sensors to obtain the patient's response and/or the perceived response to drug delivery. For example, a patient planning to eat a large amount of food may input user data into the user interface 80, since food intake is a factor that may influence the patient's response to the first drug dosing regimen. The computer system 800 is configured to send the user data to the drug administration device 500. The device 500 is configured to use the user input data when determining the second drug dosing regimen for administering the drug, for example, rapid-acting insulin, immediately before the patient has a large meal, and thus apply the second drug dosing regimen that takes into account this input factor. In another example, if the patient experiences discomfort when the drug administration device 500 delivers the drug according to the first drug dosing regimen, the user can enter this feedback about his perceived reaction to the first drug dosing regimen using the user interface 80, wherein the computer system 800 can send the user data to the drug administration device 500, and then the drug administration device can determine the second drug dosing regimen, based on the user data, by, for example, decreasing the drug administration rate, the depth of advancement of the outlet channel, the speed of the outlet channel and/or acceleration of the outlet channel. Thus, the second drug dosing regimen may be adjusted to improve the patient's perceived response to drug delivery.

[00171] Fig. 15 is a schematic diagram of an exemplary embodiment of a drug administration system that includes a computer system 800 (Figs. 8 and 9), first and second drug administration devices 300a, 300b, each of which is configured to communicate with the computer system 800, at least one sensor 94a, 98a configured to receive sensor data and transmit the sensor data to the first drug administration device 300a, and at least one sensor 94b, 98b configured to receive additional sensor data and transmit the additional sensor data to the second drug administration device 300b. The drug administration system is substantially configured and used in a manner similar to that described above with respect to the drug administration system shown in Fig. 9, except that instead of a single drug administration device, the drug administration system of Fig. 15 comprises a plurality of devices 300a, 300b for administering a drug. The drug administration system of Fig. 15 includes two devices 300a, 300b for administering a drug, but the drug administration system may include any plurality of devices for administering a drug and be designed in a different manner and used similarly to the system shown in Fig. 15.

[00172] The second drug administration device 300b is configured to transmit additional sensor data obtained by the at least one sensor 94b, 98b to the computer system 800 (e.g., using the communication interface 99b of the second drug administration device 300b and the communication interface 899 of the computer system 800), and the computer system 800 is configured to transmit additional sensor data obtained from the second drug administration device 300b to the first drug administration device 300a (e.g., using the communication interface 99a of the first drug administration device 300a and the communication interface 899 of the computer system 800). The first drug administration device 300a is configured to use the additional sensor data obtained from the computer system 800 in determining the second dosing regimen. In an alternative embodiment, the computer system 800 may be configured to use the additional sensor data received from the second device 300b for administering the drug to calculate an adjustment needed for the second dosing schedule for delivering the drug contained in the first device 300a for administering the drug to the patient. This adjustment may then be transmitted from the computer system 800 to the first device 300a for administering the drug.

[00173] Using the second drug administration device 300b (and any additional drug administration devices) in the drug administration system allows the first drug administration device 300a (or the computer system 800, in embodiments in which the computer system 800 determines and sends the second dosing schedule to the first drug administration device 300a) to determine a second drug dosing schedule dependent not only on the dosing data from the computer system 800 and/or on the reading data from at least one sensor 94a, 98a thereof, but additionally on data from other sensors related to the second drug administration device 300b, in determining the second drug dosing schedule for delivering the drug contained in the first drug administration device 300a to the patient.

[00174] The second device 300b for administering a drug may be a device for administering a drug that is used by the same patient as the first device 300a for administering a drug, but which delivers a different drug than the drug of the first device 300a for administering a drug. Thus, due to this, the first device 300a for administering a drug may be configured to receive additional sensor data from the computer system 800, which indicates that the second device 300b for administering a drug has been used to deliver a certain drug to the patient after delivering the drug from the first device 300a for administering a drug in accordance with a first drug dosing schedule for delivering the drug contained in the first device 300a for administering a drug to the patient. The first device 300a for administering a drug (or the computer system 800 in embodiments in which the computer system 800 determines and sends the second dosing schedule to the first device 300a for administering a drug) can be configured to determine that the second dosing schedule of the drug should deliver the drug at a predetermined time after the second device 300b for administering the drug has been used to deliver another drug to the patient in order to avoid interference between the drugs of the first and second devices 300a, 300b for administering the drug. Alternatively, the first device 300a for administering a drug (or the computer system 800 in embodiments in which the computer system 800 determines and sends the second dosing regimen to the first device 300a for administering a drug) can be configured to determine that the second dosing regimen of the drug should deliver the drug to the patient at the same time as or shortly after the second device 300b for administering a drug delivers its drug to the patient, since the two drugs have a beneficial effect when delivered at the same time. If the drug administration system includes one or more additional devices for administering a drug, the patient can also use each of the additional devices for administering a drug and use them for a second dosing regimen of the drug that is similar to the second device 300b for administering a drug. This can further help optimize the second dosing regimen of the drug to the patient who uses the first device 300a for administering a drug.

[00175] The second drug administration device 300b may instead be a drug administration device used by another patient (e.g., another patient than the one using the first drug administration device 300a) such that the first drug administration device 300a may be configured to receive additional sensor data relating to the administration of the drug to the other patient and the other patient's response to the other drug dosing regimen(s) used by the second drug administration device 300b and to use the additional sensor data to determine a second drug dosing regimen (or the computer system 800 in embodiments in which the computer system 800 determines and sends the second dosing regimen to the first drug administration device 300a) that is optimized for the patient using the first drug administration device 300a. In this way, the first device 300a for administering a drug can be configured to implement an adjusted dosing regimen for a patient who benefits from the experience of another patient. This can accelerate the process of optimizing the drug dosing regimen. If the drug administration system includes one or more additional devices for administering a drug, each of the additional devices for administering a drug can also be used by a patient different from the patient using the first device 300a for administering a drug and can be used for a second drug dosing regimen, similarly to the second device 300b for administering a drug. This can further contribute to optimizing the current drug dosing regimen for the patient using the first device 300a for administering a drug.

[00176] At least one sensor associated with the first device 300a for administering a medicine in this illustrated embodiment comprises a location sensor 98a, which is configured and used similarly to the location sensor 98 (Fig. 5B) described above, which is configured to obtain sensor data related to the geographic location of the device 300a for administering a medicine, which is an inhaler in this illustrated embodiment (e.g., the inhaler 300 shown in Fig. 3). At least one sensor associated with the first drug administration device 300a in this illustrated embodiment also includes an environmental sensor 94a that is constructed and used similarly to the location sensor 94 (Fig. 5B) described above, which is configured to obtain data related to the environment in which the drug administration device 300a is located, which in this illustrated embodiment includes the pollen level in the environment in which the first drug administration device 300a is present. At least one sensor associated with the second drug administration device 300b in this

In the illustrated embodiment, similarly includes a location sensor 98b that is constructed and used similarly to the location sensor 98 (Fig. 5B) and includes an environment sensor 94b that is constructed and used similarly to the location sensor 94 (Fig. 5B), and in this illustrated embodiment includes the pollen level in the environment in which the second device 300b for administering a drug is located. The second device 300b for administering a drug is an inhaler in this illustrated embodiment (e.g., the inhaler 300 shown in Fig. 3). As will be understood by one of skill in the art, the pollen level (e.g., the pollen count) can be particularly important for patients using the inhaler.

[00177] Thus, in this illustrated embodiment, the second dosage regimen of the drug for the first device 300a for administering the drug is configured to be determined in dependence on the dosage data from the computer system 800, on the sensor data relating to the location of the first inhaler 300a, on the sensor data relating to the pollen level in the environment in which the first inhaler 300a is located, on the sensor data relating to the location of the second inhaler 300b, and on the sensor data relating to the pollen level in the environment in which the second inhaler 300b is located. Thus, for example, if the sensor data indicates that the first inhaler 300a is moving in a direction close to the second inhaler 300b and that the amount of pollen at the location of the second inhaler 300b is higher than that of the first inhaler 300a, the first inhaler 300a can be configured to determine a second dosage regimen of a drug with a higher dose than the first dosage regimen of a drug to proactively combat a higher level of pollen that a patient associated with the first device 300a for administering a drug may experience and, thus, improve patient comfort and results.

[00178] In other embodiments, at least one sensor associated with each of the first and second medication administration devices 300a, 300b may include additional or alternative sensors, such as one or more sensors including a patient monitoring sensor configured to receive additional sensor data related to a patient's condition, a device sensor configured to receive additional sensor data related to an environment (other than the pollen level already taken into account by the first environmental sensor 94a for the first medication administration device 300a and the second environmental sensor 94b for the second medication administration device 300b) in which the medication administration device is present, and a location sensor configured to receive additional sensor data related to a geographic location of the medication administration device. Each of the patient monitoring sensors, the device sensor, the environmental sensor, and the location sensor may have any of the features described herein with respect to such sensors.

[00179] The second drug administration device 300b may include a user interface (e.g., the user interface 80 shown in Fig. 5B discussed above) configured to receive additional user input data, and the second drug administration device 300b may be configured to transmit the additional user input data to the computer system 800, such as via a second communication interface 99b in communication with the communication interface 899 of the computer system, which may then send the additional user input data to the first drug administration device 300a or use the additional user input data to determine a second drug dosing regimen and send the determined second drug dosing regimen to the first drug administration device 300a. This user interface of the second drug administration device 300b may be present in addition to or instead of at least one sensor 94b, 98b configured to receive the additional sensor data described herein. The second device 300b for administering a drug, configured to receive and transmit user input, allows the drug administration system to determine a second drug dosing regimen dependent on user data related to the second drug administration device 300b when determining the second drug dosing regimen. The user input data may relate to factor(s) that influence the patient's response and/or perceived response to the drug dosing regimen, as described herein.

[00180] In this illustrated embodiment shown in Fig. 15, each of the first drug administration device 300a and the second drug administration device 300b includes an inhaler, such as the inhaler 300 shown in Fig. 3, but other types of drug administration devices described herein may be used for one or both of the drug administration devices 300a, 300b (and any other drug administration devices included in the drug administration system), while the drug administration system is otherwise configured and used similarly to the drug administration system shown in Fig. 15. For example, each of the first and second drug administration devices may include an infusion pump, such as the infusion pump 200 shown in Fig. 2. The first infusion pump may be configured to deliver insulin to a patient, and the second infusion pump may be configured to deliver glucagon to the same patient. Each infusion pump may include a patient sensor configured to receive sensor data related to the blood glucose level of the corresponding patient. Thus, the first infusion pump may be configured to determine a second dosage regimen of a drug for maintaining a stable blood glucose level, at least in part based on additional sensor data received by the patient sensor of the second infusion pump.

[00181] The drug administration system of Fig. 15 may also include at least one external sensor that is not coupled to either the first or second drug administration device 300a, 300b and that is configured to collect external sensor data and transmit the external sensor data to the computer system 800. The second drug dosing regimen for the first drug administration device 300b may further depend on the external sensor data received from the computer system 800. Taking into account the external sensor data allows the first drug administration device 300a (or the computer system 800 in embodiments in which the computer system 800 determines and sends the second dosing regimen to the first drug administration device 300a) to determine a second dosing regimen that is dependent on the additional data. As a result, more data can be used to determine the second drug dosing regimen, and therefore, the second drug dosing regimen can be better optimized and lead to improved patient outcomes. At least one external sensor may include any of various types of sensors. For example, at least one external sensor may include an environmental sensor that detects air quality in a particular location and transmits sensor data to the computer system 800.

[00182] As described above, the at least one sensor configured to measure data that can be used to determine a dosage regimen for a drug may be part of a drug administration device. FIG. PA shows one embodiment of such a device, wherein the autoinjector 100 includes at least one patient monitoring sensor 91. FIGS. 16A and 16B show another embodiment of such a device, an autoinjector 900 (for example, the autoinjector 100 shown in FIG. 1) that includes at least one patient monitoring sensor 991. The at least one patient monitoring sensor 991 in this illustrated embodiment comprises a temperature sensor configured to measure the body temperature of the patient 902. The temperature sensor 991 in this illustrated embodiment is a temporary scanner configured to be placed on the forehead to measure the body temperature, as shown, for example, in FIG. 16A, in which the temperature sensor 991 is located on the forehead of the patient 902. However, other types of temperature sensors can be used for the temperature sensor 991.

[00183] The autoinjector 900 also includes a user interface 980 in the form of a display configured to display information thereon. The user interface 980 in the example of Fig. 16B shows the measured temperature of the patient as 98.6 degrees Fahrenheit. As will be understood by one skilled in the art, the user interface 980 may be part of the temporary scanner 991.

[00184] The effectiveness of some drugs may be affected by a patient's body temperature that is higher than normal, such as higher than 98.6 degrees Fahrenheit. The patient's body temperature measured by the temperature sensor 991 may be used by the computer system 800 to determine a drug dosing schedule for delivering the drug to the patient 902 using the autoinjector 900. The drug dosing schedule may be a first drug dosing schedule, a second drug dosing schedule, or a drug dosing schedule following the second drug dosing schedule. As described above, the computer system 800 may be included in the autoinjector 900 or may be external to the autoinjector 900 and in electronic communication with it. The user of the auto-injector 900 may be instructed to measure the temperature of the patient prior to delivery of the drug from the auto-injector 900 to ensure that the drug dosing regimen is adjusted by the computer system 800, if necessary, prior to delivery of the drug based on the measured body temperature of the patient. The user may be instructed in any of a variety of ways, such as verbally by a healthcare professional, via an Instruction for Use (IFU) for the injector, via a printed prescription label on the auto-injector packaging, via the user interface 980 (and/or another user interface of the auto-injector 900), etc.

[00185] In one embodiment, the auto-injector 900 is configured to control a mechanism for preventing the operation of a device in the auto-injector 900 (for example, a safety mechanism 140 of the device shown in Fig. 1) to ensure that the auto-injector 900 operates in accordance with a drug dosing regimen if the temperature sensor 991 detects that the temperature of the patient 902 is below a predetermined upper threshold, which corresponds to a temperature above which the effectiveness of the drug may be adversely affected if it is delivered to a patient 902 having such a temperature or higher. One example of a predetermined upper threshold is a normal body temperature of 98.6 degrees Fahrenheit. The autoinjector 900 is also configured to control a mechanism for preventing the operation of the device in the autoinjector 900 (for example, the safety mechanism 140 of the device shown in Fig. 1) to prevent the operation of the autoinjector 900 before delivering a drug in accordance with the drug dosing schedule, if the temperature sensor 991 detects that the temperature of the patient 902 is equal to or higher than the predetermined upper threshold. The user interface 980 (or another user interface of the autoinjector 900) can be configured to provide a user with a notification that the autoinjector 900 is temporarily disabled from use due to the current body temperature of the patient. The user can be instructed to measure the patient's temperature again after each measurement of the patient's temperature by the temperature sensor 991 so that it is equal to or higher than the predetermined upper threshold, in order to ensure that the autoinjector 900 can be activated for operation after the measured patient temperature is below the predetermined upper threshold. The user may be instructed in any of a variety of ways, such as via the Instructions for Use (IFU), via a printed prescription label on the auto-injector packaging, via the user interface 980 (and/or another user interface of the auto-injector 900), etc. The user may be instructed to wait a certain amount of time before re-measuring the patient's temperature.

[00186] The patient's body temperature may be a biometric indicator that is important in understanding the long-term effects of a drug on the patient, as will be appreciated by one of skill in the art. Thus, the patient's body temperature measured by the temperature sensor 991 immediately before the delivery of the drug may be useful for assessing the long-term effects of the drug delivered to the patient 902 using the auto-injector 900. Thus, in some embodiments, the patient's temperature measured by the temperature sensor 991 may be used by the computer system 800 and/or the health care professional in determining the drug dosing regimen and in assessing the long-term effect of the drug by correlating the measured patient's body temperature with each drug delivery to the patient from the auto-injector 900 and any other auto-injectors 900. In some embodiments, the patient's temperature sensed by the temperature sensor 991 may not be used at all in determining the drug dosing regimen, but may be used by the computer system 800 and/or the health care professional in assessing the long-term effect of the drug by correlating the measured patient's body temperature with each drug delivery to the patient from the auto-injector 900 and any other auto-injectors 900.

[00187] All of the devices and systems described herein may be designed to be disposed of after a single use or may be designed to be reused multiple times. However, in either case, the devices may be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembling the devices, then cleaning or replacing specific parts, and then reassembling. In particular, the devices may be disassembled and any number of specific parts or portions of the device may be selectively replaced or removed in any combination. After cleaning and/or replacing specific parts, the devices may be reassembled for subsequent use either in a reconditioning shop or by a surgical team immediately prior to surgery. Those skilled in the art will appreciate that various techniques of disassembling, cleaning, replacing, and reassembling may be used to recondition the device. The use of such techniques, as well as the resulting reconditioned device, are within the scope of the present application.

[00188] Preferably, the devices described herein are sterilized prior to use. This can be accomplished by a number of methods known to those skilled in the art, including beta or gamma radiation, ethylene oxide, steam, and a liquid bath (e.g., soaking at a reduced temperature). An exemplary embodiment for sterilizing a device, including internal circuitry, is described in more detail in U.S. Patent Publication No. 2009/0202387, published August 13, 2009, entitled "System And Method Of Sterilizing An Implantable Medical Device." Preferably, the implanted device is hermetically sealed. This can be accomplished by any number of methods known to those skilled in the art.

[00189] The present invention has been described above by way of example only in the context of the full disclosure provided herein. It should be understood that modifications within the spirit and scope of the claims may be made without departing from the general scope of the present invention.

Claims (60)

1. A system for administering a medicinal product, comprising: a device for administering a medicinal product, comprising a communication interface configured to exchange data with a communication interface of a computer system; at least one sensor configured to receive sensor data and transmit sensor data to a drug administration device; and wherein: the device for administering a medicinal product is designed with the ability to: using a first dosage regimen of the drug, where the drug is delivered from the drug administration device to the patient; determining a second drug dosing regimen for delivering the drug from the drug administration device to the patient, wherein the second drug dosing regimen depends on the following: dosing data from a computer system and sensor data from at least one sensor obtained by at least one sensor during and/or after delivery of the drug in accordance with a first drug dosing regimen; and use of a second drug administration scheme where the drug is delivered from the drug administration device to the patient. 2. The drug administration system of claim 1, wherein the drug administration device is configured to determine a first drug dosing schedule for delivering the drug to the patient prior to using the first drug dosing schedule when the drug is delivered from the drug administration device to the patient. 3. A system for administering a medicinal product, comprising: a device for administering a medicinal product, comprising a communication interface configured to exchange data with a communication interface of a computer system; at least one user interface configured to receive data input by a user and to transmit data input by a user to a device for administering a medicinal product; and wherein: the device for administering a medicinal product is designed with the ability to: using a first dosage regimen of the drug, where the drug is delivered from the drug administration device to the patient; determining a second drug dosing regimen for delivering the drug from the drug administration device to the patient, wherein the second drug dosing regimen depends on the following: dosing data from a computer system and user input data from at least one user interface and received by the user interface during and/or after delivery of the drug from the drug administration device in accordance with a first drug dosing regimen; and using a second drug dosing regimen where the drug is delivered from a drug administration device to the patient. 4. The drug administration system of claim 3, wherein the drug administration device is configured to determine a first drug dosing schedule for delivering the drug from the drug administration device to the patient prior to using the first drug dosing schedule when the drug is delivered from the drug administration device to the patient. 5. The drug administration system of claim 3 or 4, further comprising at least one sensor configured to receive sensor data and transmit the sensor data to the drug administration device; and wherein the drug administration device is configured to determine a second drug dosing regimen, further depending on the sensor data from the at least one sensor received by the at least one sensor during and/or after drug delivery from the drug administration device in accordance with the first drug dosing regimen. 6. A drug administration system according to any one of claims 1-5, wherein each of the first and second drug dosing regimens comprises one or more of the following drug dosing parameters: drug delivery speed; time and/or date of administration of the drug; the volume of the drug; and duration of drug delivery. 7. The drug administration system according to claims 1, 2, 5 when dependent on claim 3, or 4, or 6 when dependent on any of claims 1, 2 and 5, wherein at least one sensor comprises one or more of: a patient monitoring sensor configured to receive sensor data relating to a patient's condition; a device sensor configured to receive sensor data related to the drug administration device; an environmental sensor configured to receive sensor data relating to an environment in which the drug administration device is present; and a location sensor configured to receive sensor data relating to the geographic location of the drug administration device. 8. A drug administration system according to any one of paragraphs 1-7, further comprising: at least one external sensor configured to receive external sensor data and transmit external sensor data to a computer system; and wherein the second drug dosing regimen is further defined as dependent on external sensor data from the computer system. 9. A drug administration system according to any one of paragraphs 1-8, further comprising: a second device for administering a medicinal product, comprising a communication interface configured to exchange data with a communication interface of a computer system; at least one sensor configured to receive additional sensor data and transmit additional sensor data to a second device for administering a drug; and The second drug dosing regimen is further defined as dependent on additional sensor data from the computer system. 10. A drug administration system according to any one of paragraphs 1-8, further comprising: a second device for administering a medicinal product, comprising a communication interface configured to exchange data with a communication interface of a computer system; and at least one user interface configured to receive additional user input data and transmit the additional user input data to the second device for administering the drug; and wherein the second dosage regimen of the drug is further defined as dependent on additional user data from the computer system. 11. The drug administration system of claim 10, further comprising at least one sensor configured to receive additional sensor data and transmit additional sensor data to a second drug administration device; and wherein the second dosage regimen of the drug is additionally defined as dependent on the data of an additional sensor from the computer system. 12. A drug administration system according to claim 9 or 11, wherein at least one sensor configured to receive additional sensor data comprises one or more of: a patient monitoring sensor configured to receive additional sensor data relating to the patient's condition; a device sensor configured to receive additional sensor data related to a second device for administering a medicinal product; an environmental sensor configured to receive additional sensor data relating to an environment in which the second drug administration device is present; and a location sensor configured to receive additional sensor data relating to the geographic location of the second drug administration device. 13. A drug delivery system according to any one of claims 1-12, wherein the drug delivery device is an autoinjector and wherein the first and second drug dosing regimens determine one or more of the following dosing parameters: the depth of advancement of the outlet channel during the delivery of the drug to the patient, the velocity of the outlet port during delivery of the drug to the patient; and acceleration of the outlet channel during delivery of the drug to the patient. 14. A drug administration system according to any one of claims 1-10, wherein the drug administration device is an inhaler. 15. A drug administration system according to any one of claims 1-10, wherein the drug administration device is an infusion pump. 16. A system for administering a medicinal product according to any one of claims 2, 4 or any one of claims 5-15 when dependent on claim 2 or 4, wherein the first dosage regimen of the medicinal product is determined depending on the dosage data transmitted from the computer system. 17. A drug administration system according to any one of paragraphs 1-16, in which: the first and second drug dosing regimens indicate one or more of the following drug dosing parameters: drug delivery speed; the volume of the drug; and duration of drug delivery; and where the value of one or more parameters in the first dosage regimen of the drug differs from the value of the corresponding parameter in the second dosage regimen of the drug. 18. A drug delivery system according to any one of the preceding claims, wherein the drug comprises at least one of the following: infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

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